{
    "info": {
        "nct_id": "NCT05420220",
        "official_title": "An Open-Label, Multi-Center, Phase 2 Clinical Study to Evaluate Efficacy, Safety, and Tolerability of KN046 in Combination With Axitinib in Subjects With Advanced Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* I01. Subjects who are able to understand the Informed Consent Form (ICF) and sign the ICF;\n* I02. Male or female subjects, aged 18 years or older; willing and able to complete all required study procedures;\n* I03. Subjects with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) and stage IV (defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System, edition 8) non-small cell lung cancer that is unresectable and unable to receive radical chemoradiotherapy;\n* I04. Subjects who are PD-L1+ (TPS ≥ 1%) confirmed by central laboratory;\n* I05. Subjects who must have negative EGFR mutation and ALK translocation (testing is not mandatory for subjects with squamous cell carcinoma whose EGFR/ALK gene mutation status is unknown). Subjects with known driver genes for other approved targeted drug therapies are also not eligible.\n* I06. Subjects who have not received systemic therapy for locally advanced/metastatic NSCLC. Subjects who have received prior neoadjuvant, adjuvant chemotherapy, or radical chemoradiotherapy are allowed if they develop progressive disease at least 6 months after completing the aforementioned treatment;\n* I07. Subjects with at least one measurable lesion per RECIST v1.1 at baseline;\n* I08. Subjects with a ECOG score of 0 or 1;\n* I09. Subjects with adequate organ function assessed within 7 days prior to first trial treatment as follows:\n\n  • Hematology (without transfusion or use of hematopoietic stimulators within 14 days prior to enrollment)\n* ANC≥1.5 × 109/L;\n* Hemoglobin ≥ 9 g/dL;\n* Platelets ≥ 100 × 109/L;\n* White blood cell count (WBC) ≥ 4.0 × 109/L and ≤ 15 × 109/L;\n\n  • Renal function\n* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault method, see Appendix 7 for details);\n* Urine protein < 2+ by urinalysis. If urine protein is ≥ 2+, the subject is eligible only if 24-hour urine protein is < 1.0 g/24 hours;\n\n  • Hepatic function\n* Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for subjects with Giltert's syndrome);\n* ALT/AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastases);\n\n  • Coagulation\n* INR or PT ≤ 1.5 × ULN\n* aPTT≤1.5 × ULN;\n* I10. Subjects with a left ventricular ejection fraction (LVEF) of ≥ 50% (by ECHO or MUGA assessment)\n* I11. Subjects who have a life expectancy of ≥ 3 months;\n* I12. Female subjects of childbearing potential who have a negative serum pregnancy test within 7 days prior to the first dose;\n\nExclusion Criteria\n\n* E01. Subjects with untreated metastases to central nervous system. Subjects with a previous diagnosis of metastases to central nervous system are eligible to enroll if they have completed treatment, have been clinically stable (assessed by imaging, preferably MRI with contrast-enhanced MRI or CT) for at least 2 weeks, and their neurological and other clinical symptoms have recovered to ≤ Grade 1 per NCI-CTC AE at least 2 weeks before the first dose, and steroids for brain metastases are discontinued 7 days prior to the first dose of trial treatment.\n* E02. Subjects who have received prior immune checkpoint inhibitors, including but not limited to anti-PD-1, PD-L1, CTLA-4, LAG3 agent or other immune checkpoint inhibitors; Subjects who have received prior treatment with single/multi-target inhibitors or monoclonal antibodies to VEGF or VEGFR signaling pathways;\n* E03. Subjects who have undergone major surgery for any reason within 4 weeks prior to the first dose of trial treatment;\n* E04. Subjects who have a history of radiotherapy that meets the following criteria and fail to recover from toxicity/complications of radiotherapy to ≤ Grade 1 per NCI-CTCAE (except alopecia and fatigue)\n\n  1. Thoracic radiotherapy: subjects who have received a chest radiation dose of > 30 Gy within 24 weeks before the first dose;\n  2. Non-thoracic radiotherapy: subjects who have received a non-thoracic radiotherapy with a dose of > 30 Gy within 4 weeks before the first dose.\n  3. Subjects who have received palliative radiotherapy with a dose of ≤ 30 Gy within 2 weeks before the first dose; Palliative radiotherapy for symptom control is permitted and must be completed at least 2 weeks before the start of study drug.\n* E05. Subjects who have participated in a study or received the treatment with other investigational drugs within 4 weeks or less than 5 times of half-life (not less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;\n* E06. Subjects who have received treatment with anti-tumor vaccines, anti-tumor traditional Chinese medicine or other anti-tumor drugs with immunostimulatory effects within 2 weeks prior to the first dose;\n* E07. Subjects who require systemic corticosteroids (≥ 10 mg/day prednisone or equivalent dose of other corticosteroids) or immunosuppressive therapy for 7 consecutive days within 14 days prior to the first dose; except inhaled or topical corticosteroids, or physiologic replacement doses of corticosteroids for adrenal insufficiency; short-term (≤ 7 days) corticosteroids are allowed for prophylaxis (e.g., contrast media allergy) or for the treatment of non-autoimmune disorders (e.g., delayed-type hypersensitivity reactions due to contact allergens);\n* E08. Subjects who have received vaccination within 28 days prior to the first dose of trial treatment, except for inactivated vaccines.\n* E09. Subjects who have interstitial lung disease, or a history of pneumonia requiring oral or intravenous corticosteroids to assist in management;\n* E10. Subjects with uncontrolled hypertension (blood pressure ≥ 150/95 mmHg at rest) after standard antihypertensive therapy.\n* E11. Subjects who have a history of or current autoimmune diseases, including, but not limited to, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (refer to the following exceptions), autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome).\n* E12. Subjects who have other malignancies within 5 years before the first dose, except cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL (as measured) at diagnosis of prostate cancer, the subjects had received curative treatment and no prostate-specific antigen (PSA) biochemical recurrence), and in-situ cervical/breast cancer;\n* E13. Subjects with uncontrolled comorbidities, including but not limited to:\n\n  * Active HBV or HCV infection;\n  * Known HIV infection or known history of acquired immune deficiency syndrome (AIDS);\n  * Active tuberculosis infection;\n  * Active infection within 4 weeks prior to the first dose of trial treatment that requires the use of systemic antibiotics ≥ 7 days;\n  * Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated (monthly or more frequent) drainage\n  * Clinically significant (that is, active) cardiovascular disease:\n  * Uncontrolled ≥ Grade 3 active hemorrhage by medical intervention within 4 weeks prior to the first dose of trial treatment;\n  * Subjects who require long-term anticoagulant therapy with warfarin (prophylactic anticoagulation for maintenance of the venous access device is permitted); Subjects who require long-term antiplatelet therapy (e.g., aspirin or clopidogrel at loading dose; or aspirin at maintenance dose of ≥ 100 mg/day; or clopidogrel at maintenance dose of ≥ 75 mg/day).\n  * Serious, non-healing wound, ulcer, or bone fracture;\n* E14. Subjects whose tumor has invaded important blood vessels or, as judged by the investigator, the tumor is highly likely to invade important blood vessels and cause major hemorrhage during treatment.\n* E15. Subjects with impaired gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Axitinib, including but not limited to:\n\n  * Inability to take oral medication\n  * Prior surgical procedures affecting absorption including total/partial gastric resection;\n  * Malabsorption syndromes, uncontrolled nausea, vomiting, diarrhea.\n* E16. Subjects with current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or CYP3A4/5 inducers within 14 days prior to the first dose of trial treatment (e.g., grapefruit juice or grapefruit/grapefruit-related citrus fruits [e.g., oranges, pomelos], ketoconazole, miconazole etc. ). The topical use of these medications (if applicable) such as 2% ketoconazole cream is allowed;\n* E17. Subjects with current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers within 14 days prior to enrollment or thereafter (e.g., phenobarbital, rifampin);\n* E18. Subjects with toxicity related to prior therapy (including any prior investigational therapy) that has not recovered to ≤ Grade 1 per CTCAE (NCI-CTCAE v5.0) or baseline, except for alopecia of any grade;\n* E19. Subjects who have received prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* E20. Subjects who have known serious hypersensitivity to antibody drugs (≥ Grade 3 per NCI-CTCAE v5.0), any history of serious drug hypersensitivity (e.g., immune-mediated hepatotoxicity, immune-mediated thrombocytopenia or anemia); or known allergy to the study drug or any of its excipients\n* E21. Pregnant or lactating women;\n* E22. Subjects with other medical conditions that at the discretion of investigator affect the safety or efficacy assessment or treatment compliance of the trial. These include, but are not limited to, mental illness, alcoholism, drug addiction or drug abuse.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* I01. Subjects who are able to understand the Informed Consent Form (ICF) and sign the ICF;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are able to understand the Informed Consent Form (ICF)",
                    "criterion": "understanding of Informed Consent Form",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the ICF",
                    "criterion": "signing of Informed Consent Form",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I02. Male or female subjects, aged 18 years or older; willing and able to complete all required study procedures;",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to complete all required study procedures",
                    "criterion": "willingness and ability to complete study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I03. Subjects with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) and stage IV (defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System, edition 8) non-small cell lung cancer that is unresectable and unable to receive radical chemoradiotherapy;",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced (stage IIIB/IIIC) and stage IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IIIC",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "non-small cell lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-small cell lung cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to receive radical chemoradiotherapy",
                    "criterion": "ability to receive radical chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I04. Subjects who are PD-L1+ (TPS ≥ 1%) confirmed by central laboratory;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are PD-L1+ (TPS ≥ 1%) confirmed by central laboratory",
                    "criterion": "PD-L1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "TPS",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I05. Subjects who must have negative EGFR mutation and ALK translocation (testing is not mandatory for subjects with squamous cell carcinoma whose EGFR/ALK gene mutation status is unknown). Subjects with known driver genes for other approved targeted drug therapies are also not eligible.",
            "criterions": [
                {
                    "exact_snippets": "negative EGFR mutation",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "negative ... ALK translocation",
                    "criterion": "ALK translocation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known driver genes for other approved targeted drug therapies",
                    "criterion": "driver genes for other approved targeted drug therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I06. Subjects who have not received systemic therapy for locally advanced/metastatic NSCLC. Subjects who have received prior neoadjuvant, adjuvant chemotherapy, or radical chemoradiotherapy are allowed if they develop progressive disease at least 6 months after completing the aforementioned treatment;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have not received systemic therapy for locally advanced/metastatic NSCLC.",
                    "criterion": "systemic therapy for locally advanced/metastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received prior neoadjuvant, adjuvant chemotherapy, or radical chemoradiotherapy are allowed if they develop progressive disease at least 6 months after completing the aforementioned treatment",
                    "criterion": "prior neoadjuvant, adjuvant chemotherapy, or radical chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progressive disease development",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since treatment completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I07. Subjects with at least one measurable lesion per RECIST v1.1 at baseline;",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion per RECIST v1.1 at baseline",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I08. Subjects with a ECOG score of 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG score of 0 or 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I09. Subjects with adequate organ function assessed within 7 days prior to first trial treatment as follows:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Hematology (without transfusion or use of hematopoietic stimulators within 14 days prior to enrollment)",
            "criterions": [
                {
                    "exact_snippets": "Hematology (without transfusion or use of hematopoietic stimulators within 14 days prior to enrollment)",
                    "criterion": "hematology",
                    "requirements": [
                        {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "use of hematopoietic stimulators",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC≥1.5 × 109/L;",
            "criterions": [
                {
                    "exact_snippets": "ANC≥1.5 × 109/L",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9 g/dL;",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100 × 109/L;",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100 × 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count (WBC) ≥ 4.0 × 109/L and ≤ 15 × 109/L;",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count (WBC) ≥ 4.0 × 109/L and ≤ 15 × 109/L",
                    "criterion": "white blood cell count (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4.0,
                                        "unit": "× 109/L"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "× 109/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Renal function",
            "criterions": [
                {
                    "exact_snippets": "Renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault method, see Appendix 7 for details);",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 × upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault method",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urine protein < 2+ by urinalysis. If urine protein is ≥ 2+, the subject is eligible only if 24-hour urine protein is < 1.0 g/24 hours;",
            "criterions": [
                {
                    "exact_snippets": "Urine protein < 2+ by urinalysis",
                    "criterion": "urine protein by urinalysis",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If urine protein is ≥ 2+ ... 24-hour urine protein is < 1.0 g/24 hours",
                    "criterion": "urine protein by urinalysis",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour urine protein is < 1.0 g/24 hours",
                    "criterion": "24-hour urine protein",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "g/24 hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for subjects with Giltert's syndrome);",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 × ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 3 × ULN for subjects with Giltert's syndrome",
                    "criterion": "total bilirubin in subjects with Giltert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT/AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastases);",
            "criterions": [
                {
                    "exact_snippets": "ALT/AST ≤ 2.5 × ULN",
                    "criterion": "ALT/AST levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT/AST ... ≤ 5.0 × ULN for subjects with liver metastases",
                    "criterion": "ALT/AST levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Coagulation",
            "criterions": [
                {
                    "exact_snippets": "Coagulation",
                    "criterion": "coagulation",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR or PT ≤ 1.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": "INR or PT ≤ 1.5 × ULN",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "INR or PT ≤ 1.5 × ULN",
                    "criterion": "PT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* aPTT≤1.5 × ULN;",
            "criterions": [
                {
                    "exact_snippets": "aPTT≤1.5 × ULN",
                    "criterion": "aPTT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I10. Subjects with a left ventricular ejection fraction (LVEF) of ≥ 50% (by ECHO or MUGA assessment)",
            "criterions": [
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF) of ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I11. Subjects who have a life expectancy of ≥ 3 months;",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* I12. Female subjects of childbearing potential who have a negative serum pregnancy test within 7 days prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test within 7 days prior to the first dose",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E01. Subjects with untreated metastases to central nervous system. Subjects with a previous diagnosis of metastases to central nervous system are eligible to enroll if they have completed treatment, have been clinically stable (assessed by imaging, preferably MRI with contrast-enhanced MRI or CT) for at least 2 weeks, and their neurological and other clinical symptoms have recovered to ≤ Grade 1 per NCI-CTC AE at least 2 weeks before the first dose, and steroids for brain metastases are discontinued 7 days prior to the first dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "untreated metastases to central nervous system",
                    "criterion": "metastases to central nervous system",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous diagnosis of metastases to central nervous system",
                    "criterion": "metastases to central nervous system",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis history",
                            "expected_value": "previous diagnosis"
                        }
                    ]
                },
                {
                    "exact_snippets": "completed treatment",
                    "criterion": "treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "completion status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically stable (assessed by imaging, preferably MRI with contrast-enhanced MRI or CT) for at least 2 weeks",
                    "criterion": "clinical stability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological and other clinical symptoms have recovered to ≤ Grade 1 per NCI-CTC AE",
                    "criterion": "neurological and clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade (NCI-CTC AE)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids for brain metastases are discontinued 7 days prior to the first dose of trial treatment",
                    "criterion": "steroid use for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E02. Subjects who have received prior immune checkpoint inhibitors, including but not limited to anti-PD-1, PD-L1, CTLA-4, LAG3 agent or other immune checkpoint inhibitors; Subjects who have received prior treatment with single/multi-target inhibitors or monoclonal antibodies to VEGF or VEGFR signaling pathways;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have received prior immune checkpoint inhibitors, including but not limited to anti-PD-1, PD-L1, CTLA-4, LAG3 agent or other immune checkpoint inhibitors",
                    "criterion": "prior immune checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received prior treatment with single/multi-target inhibitors or monoclonal antibodies to VEGF or VEGFR signaling pathways",
                    "criterion": "prior treatment with VEGF or VEGFR inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E03. Subjects who have undergone major surgery for any reason within 4 weeks prior to the first dose of trial treatment;",
            "criterions": [
                {
                    "exact_snippets": "undergone major surgery ... within 4 weeks prior to the first dose of trial treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E04. Subjects who have a history of radiotherapy that meets the following criteria and fail to recover from toxicity/complications of radiotherapy to ≤ Grade 1 per NCI-CTCAE (except alopecia and fatigue)",
            "criterions": [
                {
                    "exact_snippets": "history of radiotherapy",
                    "criterion": "history of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fail to recover from toxicity/complications of radiotherapy to ≤ Grade 1 per NCI-CTCAE",
                    "criterion": "recovery from radiotherapy toxicity/complications",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade (NCI-CTCAE)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Thoracic radiotherapy: subjects who have received a chest radiation dose of > 30 Gy within 24 weeks before the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Thoracic radiotherapy: subjects who have received a chest radiation dose of > 30 Gy within 24 weeks before the first dose",
                    "criterion": "thoracic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "Gy"
                            }
                        },
                        {
                            "requirement_type": "time since dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Non-thoracic radiotherapy: subjects who have received a non-thoracic radiotherapy with a dose of > 30 Gy within 4 weeks before the first dose.",
            "criterions": [
                {
                    "exact_snippets": "Non-thoracic radiotherapy: subjects who have received a non-thoracic radiotherapy",
                    "criterion": "non-thoracic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a dose of > 30 Gy",
                    "criterion": "radiotherapy dose",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "Gy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks before the first dose",
                    "criterion": "time since radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subjects who have received palliative radiotherapy with a dose of ≤ 30 Gy within 2 weeks before the first dose; Palliative radiotherapy for symptom control is permitted and must be completed at least 2 weeks before the start of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have received palliative radiotherapy",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "Gy"
                            }
                        },
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Palliative radiotherapy for symptom control is permitted",
                    "criterion": "palliative radiotherapy for symptom control",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E05. Subjects who have participated in a study or received the treatment with other investigational drugs within 4 weeks or less than 5 times of half-life (not less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have participated in a study",
                    "criterion": "participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received the treatment with other investigational drugs within 4 weeks or less than 5 times of half-life (not less than 2 weeks), whichever is shorter",
                    "criterion": "treatment with other investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "whichever is shorter: 4 weeks or less than 5 times of half-life (not less than 2 weeks)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E06. Subjects who have received treatment with anti-tumor vaccines, anti-tumor traditional Chinese medicine or other anti-tumor drugs with immunostimulatory effects within 2 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have received treatment with anti-tumor vaccines",
                    "criterion": "treatment with anti-tumor vaccines",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received treatment with ... anti-tumor traditional Chinese medicine",
                    "criterion": "treatment with anti-tumor traditional Chinese medicine",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have received treatment with ... other anti-tumor drugs with immunostimulatory effects",
                    "criterion": "treatment with other anti-tumor drugs with immunostimulatory effects",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E07. Subjects who require systemic corticosteroids (≥ 10 mg/day prednisone or equivalent dose of other corticosteroids) or immunosuppressive therapy for 7 consecutive days within 14 days prior to the first dose; except inhaled or topical corticosteroids, or physiologic replacement doses of corticosteroids for adrenal insufficiency; short-term (≤ 7 days) corticosteroids are allowed for prophylaxis (e.g., contrast media allergy) or for the treatment of non-autoimmune disorders (e.g., delayed-type hypersensitivity reactions due to contact allergens);",
            "criterions": [
                {
                    "exact_snippets": "require systemic corticosteroids (≥ 10 mg/day prednisone or equivalent dose of other corticosteroids)",
                    "criterion": "systemic corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mg/day prednisone or equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "require ... immunosuppressive therapy for 7 consecutive days within 14 days prior to the first dose",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "7 consecutive days within 14 days prior to the first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E08. Subjects who have received vaccination within 28 days prior to the first dose of trial treatment, except for inactivated vaccines.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have received vaccination within 28 days prior to the first dose of trial treatment",
                    "criterion": "recent vaccination",
                    "requirements": [
                        {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for inactivated vaccines",
                    "criterion": "vaccine type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "inactivated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E09. Subjects who have interstitial lung disease, or a history of pneumonia requiring oral or intravenous corticosteroids to assist in management;",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of pneumonia requiring oral or intravenous corticosteroids",
                    "criterion": "history of pneumonia requiring corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E10. Subjects with uncontrolled hypertension (blood pressure ≥ 150/95 mmHg at rest) after standard antihypertensive therapy.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "blood pressure ≥ 150/95 mmHg at rest",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 95,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "after standard antihypertensive therapy",
                    "criterion": "antihypertensive therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E11. Subjects who have a history of or current autoimmune diseases, including, but not limited to, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (refer to the following exceptions), autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome).",
            "criterions": [
                {
                    "exact_snippets": "history of or current autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Crohn's disease",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sarcoidosis",
                    "criterion": "sarcoidosis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Wegener's syndrome (granulomatosis with polyangiitis",
                    "criterion": "Wegener's syndrome (granulomatosis with polyangiitis)",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Graves' disease",
                    "criterion": "Graves' disease",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypophysitis",
                    "criterion": "hypophysitis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uveitis",
                    "criterion": "uveitis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune hepatitis",
                    "criterion": "autoimmune hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic sclerosis (scleroderma",
                    "criterion": "systemic sclerosis (scleroderma)",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hashimoto's thyroiditis",
                    "criterion": "Hashimoto's thyroiditis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune vasculitis",
                    "criterion": "autoimmune vasculitis",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune neuropathy (Guillain-Barre syndrome",
                    "criterion": "autoimmune neuropathy (Guillain-Barre syndrome)",
                    "requirements": [
                        {
                            "requirement_type": "history or current presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E12. Subjects who have other malignancies within 5 years before the first dose, except cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL (as measured) at diagnosis of prostate cancer, the subjects had received curative treatment and no prostate-specific antigen (PSA) biochemical recurrence), and in-situ cervical/breast cancer;",
            "criterions": [
                {
                    "exact_snippets": "other malignancies within 5 years before the first dose",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cured skin squamous cell carcinoma",
                    "criterion": "skin squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "cured ... basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "cured ... non-muscle invasive bladder cancer",
                    "criterion": "non-muscle invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL (as measured) at diagnosis of prostate cancer, the subjects had received curative treatment and no prostate-specific antigen (PSA) biochemical recurrence)",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "T"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "Gleason score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "PSA",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "localized low-risk"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "curative"
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": "no PSA biochemical recurrence"
                        }
                    ]
                },
                {
                    "exact_snippets": "cured ... in-situ cervical/breast cancer",
                    "criterion": "in-situ cervical/breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E13. Subjects with uncontrolled comorbidities, including but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled comorbidities",
                    "criterion": "comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active HBV or HCV infection;",
            "criterions": [
                {
                    "exact_snippets": "Active HBV",
                    "criterion": "HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... HCV infection",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV infection or known history of acquired immune deficiency syndrome (AIDS);",
            "criterions": [
                {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of acquired immune deficiency syndrome (AIDS)",
                    "criterion": "acquired immune deficiency syndrome (AIDS)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active tuberculosis infection;",
            "criterions": [
                {
                    "exact_snippets": "Active tuberculosis infection",
                    "criterion": "tuberculosis infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection within 4 weeks prior to the first dose of trial treatment that requires the use of systemic antibiotics ≥ 7 days;",
            "criterions": [
                {
                    "exact_snippets": "Active infection within 4 weeks prior to the first dose of trial treatment",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to the first dose of trial treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "requires the use of systemic antibiotics ≥ 7 days",
                    "criterion": "use of systemic antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated (monthly or more frequent) drainage",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring repeated (monthly or more frequent) drainage",
                    "criterion": "effusion or ascites drainage frequency",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant (that is, active) cardiovascular disease:",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant (that is, active) cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled ≥ Grade 3 active hemorrhage by medical intervention within 4 weeks prior to the first dose of trial treatment;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled ≥ Grade 3 active hemorrhage",
                    "criterion": "active hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": ">= Grade 3"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to the first dose of trial treatment",
                    "criterion": "time since medical intervention for hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "time since intervention",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who require long-term anticoagulant therapy with warfarin (prophylactic anticoagulation for maintenance of the venous access device is permitted); Subjects who require long-term antiplatelet therapy (e.g., aspirin or clopidogrel at loading dose; or aspirin at maintenance dose of ≥ 100 mg/day; or clopidogrel at maintenance dose of ≥ 75 mg/day).",
            "criterions": [
                {
                    "exact_snippets": "Subjects who require long-term anticoagulant therapy with warfarin",
                    "criterion": "long-term anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "warfarin"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who require long-term antiplatelet therapy",
                    "criterion": "long-term antiplatelet therapy",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "aspirin",
                                "clopidogrel"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aspirin at maintenance dose of ≥ 100 mg/day",
                    "criterion": "aspirin maintenance dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clopidogrel at maintenance dose of ≥ 75 mg/day",
                    "criterion": "clopidogrel maintenance dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious, non-healing wound, ulcer, or bone fracture;",
            "criterions": [
                {
                    "exact_snippets": "Serious, non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious, non-healing ... ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious, non-healing ... bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E14. Subjects whose tumor has invaded important blood vessels or, as judged by the investigator, the tumor is highly likely to invade important blood vessels and cause major hemorrhage during treatment.",
            "criterions": [
                {
                    "exact_snippets": "tumor has invaded important blood vessels",
                    "criterion": "tumor invasion of blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor is highly likely to invade important blood vessels",
                    "criterion": "likelihood of tumor invasion of blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E15. Subjects with impaired gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Axitinib, including but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "impaired gastrointestinal function",
                    "criterion": "gastrointestinal function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal disease that may significantly alter the absorption of Axitinib",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on Axitinib absorption",
                            "expected_value": "may significantly alter"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to take oral medication",
            "criterions": [
                {
                    "exact_snippets": "Inability to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior surgical procedures affecting absorption including total/partial gastric resection;",
            "criterions": [
                {
                    "exact_snippets": "Prior surgical procedures affecting absorption including total/partial gastric resection",
                    "criterion": "prior surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "effect on absorption",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malabsorption syndromes, uncontrolled nausea, vomiting, diarrhea.",
            "criterions": [
                {
                    "exact_snippets": "Malabsorption syndromes",
                    "criterion": "malabsorption syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled nausea",
                    "criterion": "nausea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E16. Subjects with current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or CYP3A4/5 inducers within 14 days prior to the first dose of trial treatment (e.g., grapefruit juice or grapefruit/grapefruit-related citrus fruits [e.g., oranges, pomelos], ketoconazole, miconazole etc. ). The topical use of these medications (if applicable) such as 2% ketoconazole cream is allowed;",
            "criterions": [
                {
                    "exact_snippets": "current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or CYP3A4/5 inducers",
                    "criterion": "use of CYP3A4/5 inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days prior to the first dose of trial treatment",
                    "criterion": "timeframe for use of CYP3A4/5 inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The topical use of these medications (if applicable) such as 2% ketoconazole cream is allowed",
                    "criterion": "topical use of CYP3A4/5 inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E17. Subjects with current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers within 14 days prior to enrollment or thereafter (e.g., phenobarbital, rifampin);",
            "criterions": [
                {
                    "exact_snippets": "current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers",
                    "criterion": "use of strong CYP3A4/5 inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days prior to enrollment or thereafter",
                    "criterion": "timeframe for use of strong CYP3A4/5 inducers",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "14 days prior to enrollment or thereafter"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E18. Subjects with toxicity related to prior therapy (including any prior investigational therapy) that has not recovered to ≤ Grade 1 per CTCAE (NCI-CTCAE v5.0) or baseline, except for alopecia of any grade;",
            "criterions": [
                {
                    "exact_snippets": "toxicity related to prior therapy (including any prior investigational therapy) that has not recovered to ≤ Grade 1 per CTCAE (NCI-CTCAE v5.0) or baseline",
                    "criterion": "toxicity related to prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia of any grade",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any grade"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E19. Subjects who have received prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;",
            "criterions": [
                {
                    "exact_snippets": "prior allogeneic hematopoietic stem cell transplantation",
                    "criterion": "allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior ... solid organ transplantation",
                    "criterion": "solid organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E20. Subjects who have known serious hypersensitivity to antibody drugs (≥ Grade 3 per NCI-CTCAE v5.0), any history of serious drug hypersensitivity (e.g., immune-mediated hepatotoxicity, immune-mediated thrombocytopenia or anemia); or known allergy to the study drug or any of its excipients",
            "criterions": [
                {
                    "exact_snippets": "known serious hypersensitivity to antibody drugs (≥ Grade 3 per NCI-CTCAE v5.0)",
                    "criterion": "hypersensitivity to antibody drugs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade per NCI-CTCAE v5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any history of serious drug hypersensitivity (e.g., immune-mediated hepatotoxicity, immune-mediated thrombocytopenia or anemia)",
                    "criterion": "serious drug hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known allergy to the study drug or any of its excipients",
                    "criterion": "allergy to the study drug or any of its excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E21. Pregnant or lactating women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* E22. Subjects with other medical conditions that at the discretion of investigator affect the safety or efficacy assessment or treatment compliance of the trial. These include, but are not limited to, mental illness, alcoholism, drug addiction or drug abuse.",
            "criterions": [
                {
                    "exact_snippets": "other medical conditions ... affect the safety or efficacy assessment or treatment compliance",
                    "criterion": "other medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "affect the safety or efficacy assessment or treatment compliance"
                        }
                    ]
                },
                {
                    "exact_snippets": "mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alcoholism",
                    "criterion": "alcoholism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug addiction or drug abuse",
                    "criterion": "drug addiction or drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}