{
    "info": {
        "nct_id": "NCT04699929",
        "official_title": "A Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability,Efficacy and Pharmacokinetics of YH001 in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "1. Male or female, aged ≥ 18 years;\n2. Patients with histologically or cytologically confirmed solid tumors who have failed standard of care or have no standard of care;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;\n4. Have life expectancy of at least 3 months based on investigator's judgement;\n5. Organ function levels must meet the following requirements:\n\n   A:Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin (Hb) ≥ 100 g/L ; B:Liver: serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (patients with primary liver cancer or liver metastases: AST and/or ALT < 5 × ULN); C:Kidney: creatinine clearance (CrCL) ≥ 50 mL/min;\n6. International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n7. All women of reproductive potential, men whose partner is a woman of reproductive potential, or their spouses should use adequate barrier contraception throughout the study and for 3 months after the last dose;\n8. Voluntary and agree to sign the informed consent and follow the study treatment protocol as well as follow-up plan.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded;\n2. Patients with any other malignancy within the past 5 years or currently, except for completely cured non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;\n3. Received other anti-tumor therapies (such as chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) before the first dose, or received modern Chinese medicine preparations with anti-tumor effect approved by NMPA within 2 weeks prior to the first dose;\n4. Major surgery (excluding vascular access establishment surgery) was received within 4 weeks prior to the first dose;\n5. Has received immunosuppressive therapy within 4 weeks prior to the first dose. However, enrollment is permitted under the following circumstances:\n6. In the absence of active autoimmune disease, patients are allowed to receive inhaled or topical glucocorticoids, or other glucocorticoids at doses ≤ 10 mg/day prednisone equivalent.\n\n   Patients with primary central nervous system (CNS) tumors, or symptomatic CNS tumors, or spinal cord compression, or carcinomatous meningitis; with the following exceptions:\n\n   Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms due to brain metastatic sites, no need for corticosteroids, and lesion size ≤ 1.5 cm); Patients whose symptoms are controlled by treatment, i.e., their condition is stable and asymptomatic at least 4 weeks after treatment;\n7. Use of any other study drug within 4 weeks prior to the first dose, or participation in other clinical studies;\n8. Have received live or attenuated vaccines within 4 weeks prior to the first dose;\n9. Patients with known severe allergic reactions (≥ Grade 3) to the active ingredient and excipients of the investigational drug, other monoclonal antibodies or \"Immuno-oncology drugs;\n10. Toxic and side effects caused by prior anti-tumor therapy before the first dose did not recover to ≤ Grade 1 (CTCAE v5.0), except for alopecia and sensory neuropathy below Grade 2;\n11. History of interstitial pneumonia or non-infectious pneumonitis requiring corticosteroids, except for radiation therapy, or current presence of interstitial pneumonia or non-infectious pneumonitis;\n12. ≥ Grade 2 immune-related pneumonitis occurred during prior immunotherapy;\n13. History of ≥ Grade 3 immune-related adverse reactions or any adverse reactions leading to discontinuation of immunotherapy during prior immunotherapy;\n14. Past or existing active tuberculosis ;\n15. Patients with active auto-immune disease, history of auto-immune disease requiring systemic therapy, or history of auto-immune disease within 2 years prior to the first dose, with the following exceptions: leucoderma, childhood asthma/specific reactions, type I diabetes mellitus, hypothyroidism which can be treated with replacement therapy;\n16. Clinically uncontrollable disease, including, but not limited to, severe diabetes (fasting glucose > 250 mg/dl,1 mg/dl = 18 mmol/L), uncontrollable hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or other serious disease requiring systemic treatment;\n17. Patients with active infections, including active hepatitis B, active hepatitis C, and human immunodeficiency virus infection;\n18. Patients with active infection requiring intravenous infusion;\n19. Serious cardiovascular and cerebrovascular diseases, such as cerebrovascular rupture, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure (New York Heart Association Grade ≥ II), severe uncontrolled arrhythmia, etc., occurred within 6 months prior to the first dose;\n20. Patients with clinically significant ECG abnormalities: QTcF ≥ 470 msec (corrected by Fridericia), or having history of congenital long QT syndrome, or taking any known QTc prolonging medication;\n21. Patients who have received allogeneic bone marrow transplant or organ transplant;\n22. Known psychiatric disorders, drug abuse, drug use, or alcohol dependence that may affect trial compliance;\n23. Other conditions that were considered not suitable for the study by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female, aged ≥ 18 years;",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with histologically or cytologically confirmed solid tumors who have failed standard of care or have no standard of care;",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed standard of care",
                    "criterion": "standard of care",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard of care",
                    "criterion": "standard of care",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have life expectancy of at least 3 months based on investigator's judgement;",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Organ function levels must meet the following requirements:",
            "criterions": [
                {
                    "exact_snippets": "Organ function levels",
                    "criterion": "organ function levels",
                    "requirements": [
                        {
                            "requirement_type": "levels",
                            "expected_value": "must meet the following requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "A:Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin (Hb) ≥ 100 g/L ; B:Liver: serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (patients with primary liver cancer or liver metastases: AST and/or ALT < 5 × ULN); C:Kidney: creatinine clearance (CrCL) ≥ 50 mL/min;",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin (Hb) ≥ 100 g/L",
                    "criterion": "hemoglobin (Hb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN)",
                    "criterion": "serum total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN",
                    "criterion": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with primary liver cancer or liver metastases: AST and/or ALT < 5 × ULN",
                    "criterion": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (CrCL) ≥ 50 mL/min",
                    "criterion": "creatinine clearance (CrCL)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio (INR) ≤ 1.5 × ULN",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time (PT) ≤ 1.5 × ULN",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. All women of reproductive potential, men whose partner is a woman of reproductive potential, or their spouses should use adequate barrier contraception throughout the study and for 3 months after the last dose;",
            "criterions": [
                {
                    "exact_snippets": "All women of reproductive potential",
                    "criterion": "women of reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men whose partner is a woman of reproductive potential",
                    "criterion": "men with partners of reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "their spouses should use adequate barrier contraception",
                    "criterion": "spouses",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Voluntary and agree to sign the informed consent and follow the study treatment protocol as well as follow-up plan.",
            "criterions": [
                {
                    "exact_snippets": "Voluntary and agree to sign the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow the study treatment protocol",
                    "criterion": "study treatment protocol",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow-up plan",
                    "criterion": "follow-up plan",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "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": [
        {
            "line": "1. Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded;",
            "criterions": [
                {
                    "exact_snippets": "prior anti-CTLA-4 checkpoint inhibitors",
                    "criterion": "prior anti-CTLA-4 checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with any other malignancy within the past 5 years or currently, except for completely cured non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;",
            "criterions": [
                {
                    "exact_snippets": "Patients with any other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "currently",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for completely cured non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "completely cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... ductal carcinoma in situ of the breast",
                    "criterion": "ductal carcinoma in situ of the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Received other anti-tumor therapies (such as chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) before the first dose, or received modern Chinese medicine preparations with anti-tumor effect approved by NMPA within 2 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Received other anti-tumor therapies (such as chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever is longer) before the first dose",
                    "criterion": "anti-tumor therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "5 half-lives (whichever is longer)"
                        }
                    ]
                },
                {
                    "exact_snippets": "received modern Chinese medicine preparations with anti-tumor effect approved by NMPA within 2 weeks prior to the first dose",
                    "criterion": "modern Chinese medicine preparations with anti-tumor effect",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "approved by NMPA"
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Major surgery (excluding vascular access establishment surgery) was received within 4 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Major surgery (excluding vascular access establishment surgery) was received within 4 weeks prior to the first dose",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has received immunosuppressive therapy within 4 weeks prior to the first dose. However, enrollment is permitted under the following circumstances:",
            "criterions": [
                {
                    "exact_snippets": "Has received immunosuppressive therapy within 4 weeks prior to the first dose",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. In the absence of active autoimmune disease, patients are allowed to receive inhaled or topical glucocorticoids, or other glucocorticoids at doses ≤ 10 mg/day prednisone equivalent.",
            "criterions": [
                {
                    "exact_snippets": "absence of active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allowed to receive inhaled or topical glucocorticoids",
                    "criterion": "glucocorticoid treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "inhaled",
                                "topical"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "allowed to receive ... other glucocorticoids at doses ≤ 10 mg/day prednisone equivalent",
                    "criterion": "glucocorticoid treatment",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day prednisone equivalent"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients with primary central nervous system (CNS) tumors, or symptomatic CNS tumors, or spinal cord compression, or carcinomatous meningitis; with the following exceptions:",
            "criterions": [
                {
                    "exact_snippets": "primary central nervous system (CNS) tumors",
                    "criterion": "primary CNS tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic CNS tumors",
                    "criterion": "symptomatic CNS tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms due to brain metastatic sites, no need for corticosteroids, and lesion size ≤ 1.5 cm); Patients whose symptoms are controlled by treatment, i.e., their condition is stable and asymptomatic at least 4 weeks after treatment;",
            "criterions": [
                {
                    "exact_snippets": "asymptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "no progressive central nervous system symptoms due to brain metastatic sites",
                    "criterion": "central nervous system symptoms",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no need for corticosteroids",
                    "criterion": "corticosteroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion size ≤ 1.5 cm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptoms are controlled by treatment",
                    "criterion": "symptom control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condition is stable and asymptomatic at least 4 weeks after treatment",
                    "criterion": "condition stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condition is stable and asymptomatic at least 4 weeks after treatment",
                    "criterion": "asymptomatic condition",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "at least 4 weeks after treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Use of any other study drug within 4 weeks prior to the first dose, or participation in other clinical studies;",
            "criterions": [
                {
                    "exact_snippets": "Use of any other study drug within 4 weeks prior to the first dose",
                    "criterion": "use of other study drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in other clinical studies",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Have received live or attenuated vaccines within 4 weeks prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Have received live or attenuated vaccines within 4 weeks prior to the first dose",
                    "criterion": "vaccination",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "live",
                                "attenuated"
                            ]
                        },
                        {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Toxic and side effects caused by prior anti-tumor therapy before the first dose did not recover to ≤ Grade 1 (CTCAE v5.0), except for alopecia and sensory neuropathy below Grade 2;",
            "criterions": [
                {
                    "exact_snippets": "Toxic and side effects caused by prior anti-tumor therapy before the first dose did not recover to ≤ Grade 1 (CTCAE v5.0)",
                    "criterion": "recovery from toxic and side effects",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade (CTCAE v5.0)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "sensory neuropathy below Grade 2",
                    "criterion": "sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of interstitial pneumonia or non-infectious pneumonitis requiring corticosteroids, except for radiation therapy, or current presence of interstitial pneumonia or non-infectious pneumonitis;",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... non-infectious pneumonitis requiring corticosteroids",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "corticosteroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current presence of interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current presence of ... non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. ≥ Grade 2 immune-related pneumonitis occurred during prior immunotherapy;",
            "criterions": [
                {
                    "exact_snippets": "≥ Grade 2 immune-related pneumonitis occurred during prior immunotherapy",
                    "criterion": "immune-related pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "prior immunotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of ≥ Grade 3 immune-related adverse reactions or any adverse reactions leading to discontinuation of immunotherapy during prior immunotherapy;",
            "criterions": [
                {
                    "exact_snippets": "History of ≥ Grade 3 immune-related adverse reactions",
                    "criterion": "immune-related adverse reactions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any adverse reactions leading to discontinuation of immunotherapy during prior immunotherapy",
                    "criterion": "adverse reactions leading to discontinuation of immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Past or existing active tuberculosis ;",
            "criterions": [
                {
                    "exact_snippets": "Past or existing active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "past",
                                "existing"
                            ]
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients with active auto-immune disease, history of auto-immune disease requiring systemic therapy, or history of auto-immune disease within 2 years prior to the first dose, with the following exceptions: leucoderma, childhood asthma/specific reactions, type I diabetes mellitus, hypothyroidism which can be treated with replacement therapy;",
            "criterions": [
                {
                    "exact_snippets": "Patients with active auto-immune disease",
                    "criterion": "active auto-immune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of auto-immune disease requiring systemic therapy",
                    "criterion": "history of auto-immune disease requiring systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of auto-immune disease within 2 years prior to the first dose",
                    "criterion": "history of auto-immune disease within 2 years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions: leucoderma, childhood asthma/specific reactions, type I diabetes mellitus, hypothyroidism which can be treated with replacement therapy",
                    "criterion": "auto-immune disease exceptions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "leucoderma",
                                "childhood asthma/specific reactions",
                                "type I diabetes mellitus",
                                "hypothyroidism which can be treated with replacement therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Clinically uncontrollable disease, including, but not limited to, severe diabetes (fasting glucose > 250 mg/dl,1 mg/dl = 18 mmol/L), uncontrollable hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg), or other serious disease requiring systemic treatment;",
            "criterions": [
                {
                    "exact_snippets": "Clinically uncontrollable disease",
                    "criterion": "clinically uncontrollable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe diabetes (fasting glucose > 250 mg/dl",
                    "criterion": "severe diabetes",
                    "requirements": [
                        {
                            "requirement_type": "fasting glucose level",
                            "expected_value": {
                                "operator": ">",
                                "value": 250,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable hypertension (systolic blood pressure ≥ 160 mmHg",
                    "criterion": "uncontrollable hypertension",
                    "requirements": [
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable hypertension ... diastolic blood pressure ≥ 100 mmHg",
                    "criterion": "uncontrollable hypertension",
                    "requirements": [
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious disease requiring systemic treatment",
                    "criterion": "other serious disease requiring systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients with active infections, including active hepatitis B, active hepatitis C, and human immunodeficiency virus infection;",
            "criterions": [
                {
                    "exact_snippets": "active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "active hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus infection",
                    "criterion": "human immunodeficiency virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Patients with active infection requiring intravenous infusion;",
            "criterions": [
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring intravenous infusion",
                    "criterion": "intravenous infusion",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Serious cardiovascular and cerebrovascular diseases, such as cerebrovascular rupture, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure (New York Heart Association Grade ≥ II), severe uncontrolled arrhythmia, etc., occurred within 6 months prior to the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Serious cardiovascular and cerebrovascular diseases, such as cerebrovascular rupture, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure (New York Heart Association Grade ≥ II), severe uncontrolled arrhythmia, etc.",
                    "criterion": "cardiovascular and cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular rupture",
                    "criterion": "cerebrovascular rupture",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (New York Heart Association Grade ≥ II)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "New York Heart Association Grade"
                            }
                        },
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe uncontrolled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Patients with clinically significant ECG abnormalities: QTcF ≥ 470 msec (corrected by Fridericia), or having history of congenital long QT syndrome, or taking any known QTc prolonging medication;",
            "criterions": [
                {
                    "exact_snippets": "clinically significant ECG abnormalities: QTcF ≥ 470 msec (corrected by Fridericia)",
                    "criterion": "QTcF interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taking any known QTc prolonging medication",
                    "criterion": "QTc prolonging medication",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Patients who have received allogeneic bone marrow transplant or organ transplant;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received allogeneic bone marrow transplant",
                    "criterion": "allogeneic bone marrow transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have received ... organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Known psychiatric disorders, drug abuse, drug use, or alcohol dependence that may affect trial compliance;",
            "criterions": [
                {
                    "exact_snippets": "Known psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drug use",
                    "criterion": "drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "alcohol dependence",
                    "criterion": "alcohol dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Other conditions that were considered not suitable for the study by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Other conditions that were considered not suitable for the study by the investigator.",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "not suitable for the study by the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "9. Patients with known severe allergic reactions (≥ Grade 3) to the active ingredient and excipients of the investigational drug, other monoclonal antibodies or \"Immuno-oncology drugs;",
            "criterions": [
                {
                    "exact_snippets": "known severe allergic reactions (≥ Grade 3) to the active ingredient and excipients of the investigational drug",
                    "criterion": "allergic reactions to investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "known severe allergic reactions (≥ Grade 3) to ... other monoclonal antibodies",
                    "criterion": "allergic reactions to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "known severe allergic reactions (≥ Grade 3) to ... \"Immuno-oncology drugs\"",
                    "criterion": "allergic reactions to Immuno-oncology drugs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}