{
    "info": {
        "nct_id": "NCT06682182",
        "official_title": "Tislelizumab Combined with SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer with Peritoneal Metastasis: a Prospective Cohort Study",
        "inclusion_criteria": "* Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.\n\nAge between 18 to 80 years old, Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.\n\nAmerican Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk.\n\nPeritoneal Cancer Index (PCI) ≤ 20. Good bone marrow reserve function, with blood routine meeting the following conditions: white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 90 g/L.\n\nGood organ function, with biochemical tests meeting the following conditions: Alanine aminotransferase (ALT) ≤ 2.5× upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, blood creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min.\n\nInternational Normalized Ratio (INR) ≤ 1.5, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN.\n\nUrine protein < 2+, if urine protein ≥ 2+ then 24-hour urine protein quantification must show protein ≤ 1g.\n\nAgreement to provide blood/tissue samples. Expected survival of more than 3 months. Female subjects agree to strict contraception; male subjects with partners of childbearing potential agree to use effective contraception during the study period.\n\nVoluntary signing of the informed consent form, willingness and ability to comply with planned visits, study treatments, laboratory tests, and other trial procedures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Patients who are receiving other drug clinical trials or have participated in any drug clinical trials within one month before enrollment.\n\nOther anti-tumor treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) except for study medication. Palliative external irradiation for non-target lesions is allowed.\n\nPrior use of similar chemotherapy drugs or immune checkpoint inhibitors. Presence of non-pelvic abdominal metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, etc.; patients with peritoneal metastasis in the small bowel mesentery (regions 9-12) must be excluded.\n\nGastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months before enrollment.\n\nOther untreated or concurrent tumors, except for cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients may be enrolled if the tumor was cured and there has been no evidence of disease for more than 5 years. All other tumors must have been treated at least 5 years before enrollment.\n\nSymptomatic meningioma. History of active autoimmune disease or refractory autoimmune disease. Received corticosteroids (>10mg/day prednisone or equivalent dose of steroids) or other systemic immunosuppressive therapy within 14 days before enrollment, excluding the following treatments: steroid hormone replacement therapy (≤10mg/day); local steroid therapy; and short-term prophylactic steroid therapy for allergy or nausea and vomiting.\n\nHistory of HIV infection or active hepatitis B/C virus infection. Persistent > Grade 2 bacterial, fungal, viral, or other infections.\n\nActive or clinically significant cardiac disease:\n\nCongestive heart failure > New York Heart Association (NYHA) Class 2; Active coronary artery disease; Arrhythmias requiring treatment other than beta-blockers or digoxin; Unstable angina (angina symptoms at rest), new-onset angina within 3 months before enrollment, or new myocardial infarction with unhealed wounds, ulcers, or fractures within 6 months before enrollment.\n\nPatients with renal failure requiring hemodialysis or peritoneal dialysis. Patients requiring medication for epilepsy. History of organ transplantation (including corneal transplants). Allergy or suspected allergy to the study medication or similar drugs. Pregnant or breastfeeding women. Major surgery, open biopsy, or major traumatic surgery within 4 weeks before recruitment (excluding biliary stents or percutaneous biliary drainage).\n\nHistory of vaccination within 4 weeks before enrollment. Patients deemed unsuitable for the study by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed Her-2 negative gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        },
                        {
                            "requirement_type": "Her-2 status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have not received ... other anti-cancer treatments",
                    "criterion": "other anti-cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age between 18 to 80 years old, Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.",
            "criterions": [
                {
                    "exact_snippets": "Age between 18 to 80 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status: 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk.",
            "criterions": [
                {
                    "exact_snippets": "American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1",
                    "criterion": "AJCC 8th edition TNM staging",
                    "requirements": [
                        {
                            "requirement_type": "T stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "N stage",
                            "expected_value": "Nx"
                        },
                        {
                            "requirement_type": "M stage",
                            "expected_value": "M1"
                        }
                    ]
                },
                {
                    "exact_snippets": "limited to peritoneal metastasis",
                    "criterion": "peritoneal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of ascites beyond the pelvis",
                    "criterion": "ascites beyond the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without obstruction",
                    "criterion": "obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... perforation",
                    "criterion": "perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... bleeding risk",
                    "criterion": "bleeding risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Peritoneal Cancer Index (PCI) ≤ 20. Good bone marrow reserve function, with blood routine meeting the following conditions: white blood cell count ≥ 3×10^9/L, neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 90 g/L.",
            "criterions": [
                {
                    "exact_snippets": "Peritoneal Cancer Index (PCI) ≤ 20",
                    "criterion": "Peritoneal Cancer Index (PCI)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Good bone marrow reserve function",
                    "criterion": "bone marrow reserve function",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "white blood cell count ≥ 3×10^9/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil count ≥ 1.5×10^9/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100×10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Good organ function, with biochemical tests meeting the following conditions: Alanine aminotransferase (ALT) ≤ 2.5× upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 2.5× ULN, serum total bilirubin ≤ 1.5× ULN, blood creatinine ≤ 1.5× ULN or creatinine clearance ≥ 50 mL/min.",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ≤ 2.5× upper limit of normal (ULN)",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5× ULN",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum total bilirubin ≤ 1.5× ULN",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "blood creatinine ≤ 1.5× ULN",
                    "criterion": "blood creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥ 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "International Normalized Ratio (INR) ≤ 1.5, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN.",
            "criterions": [
                {
                    "exact_snippets": "International Normalized Ratio (INR) ≤ 1.5",
                    "criterion": "International Normalized Ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prothrombin Time (PT) ... ≤ 1.5 times ULN",
                    "criterion": "Prothrombin Time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN",
                    "criterion": "Activated Partial Thromboplastin Time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Urine protein < 2+, if urine protein ≥ 2+ then 24-hour urine protein quantification must show protein ≤ 1g.",
            "criterions": [
                {
                    "exact_snippets": "Urine protein < 2+",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if urine protein ≥ 2+ then 24-hour urine protein quantification must show protein ≤ 1g",
                    "criterion": "24-hour urine protein quantification",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "g"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Agreement to provide blood/tissue samples. Expected survival of more than 3 months. Female subjects agree to strict contraception; male subjects with partners of childbearing potential agree to use effective contraception during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Agreement to provide blood/tissue samples.",
                    "criterion": "blood/tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Expected survival of more than 3 months.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects agree to strict contraception",
                    "criterion": "contraception for female subjects",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects with partners of childbearing potential agree to use effective contraception during the study period.",
                    "criterion": "contraception for male subjects with partners of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Voluntary signing of the informed consent form, willingness and ability to comply with planned visits, study treatments, laboratory tests, and other trial procedures.",
            "criterions": [
                {
                    "exact_snippets": "Voluntary signing of the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with planned visits",
                    "criterion": "compliance with planned visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... study treatments",
                    "criterion": "compliance with study treatments",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness and ability to comply with ... other trial procedures",
                    "criterion": "compliance with other trial procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who are receiving other drug clinical trials or have participated in any drug clinical trials within one month before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are receiving other drug clinical trials",
                    "criterion": "participation in other drug clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have participated in any drug clinical trials within one month before enrollment",
                    "criterion": "participation in drug clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other anti-tumor treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) except for study medication. Palliative external irradiation for non-target lesions is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Other anti-tumor treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) except for study medication.",
                    "criterion": "anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Palliative external irradiation for non-target lesions is allowed.",
                    "criterion": "palliative external irradiation for non-target lesions",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prior use of similar chemotherapy drugs or immune checkpoint inhibitors. Presence of non-pelvic abdominal metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, etc.; patients with peritoneal metastasis in the small bowel mesentery (regions 9-12) must be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Prior use of similar chemotherapy drugs",
                    "criterion": "prior use of similar chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior use of ... immune checkpoint inhibitors",
                    "criterion": "prior use of immune checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of non-pelvic abdominal metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, etc.",
                    "criterion": "non-pelvic abdominal metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with peritoneal metastasis in the small bowel mesentery (regions 9-12) must be excluded",
                    "criterion": "peritoneal metastasis in the small bowel mesentery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Gastrointestinal perforation, obstruction, or uncontrollable diarrhea within 6 months before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal perforation ... within 6 months before enrollment.",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "obstruction ... within 6 months before enrollment.",
                    "criterion": "gastrointestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable diarrhea within 6 months before enrollment.",
                    "criterion": "uncontrollable diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other untreated or concurrent tumors, except for cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients may be enrolled if the tumor was cured and there has been no evidence of disease for more than 5 years. All other tumors must have been treated at least 5 years before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Other untreated or concurrent tumors",
                    "criterion": "other tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder tumors",
                    "criterion": "superficial bladder tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor was cured and there has been no evidence of disease for more than 5 years",
                    "criterion": "tumor cure status",
                    "requirements": [
                        {
                            "requirement_type": "cure status",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since cure",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "All other tumors must have been treated at least 5 years before enrollment",
                    "criterion": "other tumors treatment time",
                    "requirements": [
                        {
                            "requirement_type": "treatment time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Symptomatic meningioma. History of active autoimmune disease or refractory autoimmune disease. Received corticosteroids (>10mg/day prednisone or equivalent dose of steroids) or other systemic immunosuppressive therapy within 14 days before enrollment, excluding the following treatments: steroid hormone replacement therapy (≤10mg/day); local steroid therapy; and short-term prophylactic steroid therapy for allergy or nausea and vomiting.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic meningioma",
                    "criterion": "meningioma",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "refractory",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Received corticosteroids (>10mg/day prednisone or equivalent dose of steroids)",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other systemic immunosuppressive therapy within 14 days before enrollment",
                    "criterion": "systemic immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding the following treatments: steroid hormone replacement therapy (≤10mg/day)",
                    "criterion": "steroid hormone replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "local steroid therapy",
                    "criterion": "local steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "short-term prophylactic steroid therapy for allergy or nausea and vomiting",
                    "criterion": "short-term prophylactic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": [
                                "allergy",
                                "nausea and vomiting"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "History of HIV infection or active hepatitis B/C virus infection. Persistent > Grade 2 bacterial, fungal, viral, or other infections.",
            "criterions": [
                {
                    "exact_snippets": "History of HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B/C virus infection",
                    "criterion": "hepatitis B/C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Persistent > Grade 2 bacterial, fungal, viral, or other infections",
                    "criterion": "bacterial, fungal, viral, or other infections",
                    "requirements": [
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Active or clinically significant cardiac disease:",
            "criterions": [
                {
                    "exact_snippets": "Active or clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "clinically significant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Congestive heart failure > New York Heart Association (NYHA) Class 2; Active coronary artery disease; Arrhythmias requiring treatment other than beta-blockers or digoxin; Unstable angina (angina symptoms at rest), new-onset angina within 3 months before enrollment, or new myocardial infarction with unhealed wounds, ulcers, or fractures within 6 months before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure > New York Heart Association (NYHA) Class 2",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA Class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Active coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Arrhythmias requiring treatment other than beta-blockers or digoxin",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "other than beta-blockers",
                                "other than digoxin"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Unstable angina (angina symptoms at rest)",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "at rest"
                        }
                    ]
                },
                {
                    "exact_snippets": "new-onset angina within 3 months before enrollment",
                    "criterion": "new-onset angina",
                    "requirements": [
                        {
                            "requirement_type": "onset",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months before enrollment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "new myocardial infarction with unhealed wounds, ulcers, or fractures within 6 months before enrollment",
                    "criterion": "new myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "complications",
                            "expected_value": [
                                "unhealed wounds",
                                "ulcers",
                                "fractures"
                            ]
                        },
                        {
                            "requirement_type": "onset",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months before enrollment"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients with renal failure requiring hemodialysis or peritoneal dialysis. Patients requiring medication for epilepsy. History of organ transplantation (including corneal transplants). Allergy or suspected allergy to the study medication or similar drugs. Pregnant or breastfeeding women. Major surgery, open biopsy, or major traumatic surgery within 4 weeks before recruitment (excluding biliary stents or percutaneous biliary drainage).",
            "criterions": [
                {
                    "exact_snippets": "renal failure requiring hemodialysis or peritoneal dialysis",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "hemodialysis",
                                "peritoneal dialysis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring medication for epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "History of organ transplantation (including corneal transplants)",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy or suspected allergy to the study medication or similar drugs",
                    "criterion": "allergy to study medication or similar drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or breastfeeding women",
                    "criterion": "pregnancy or breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Major surgery, open biopsy, or major traumatic surgery within 4 weeks before recruitment (excluding biliary stents or percutaneous biliary drainage)",
                    "criterion": "major surgery, open biopsy, or major traumatic surgery",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "History of vaccination within 4 weeks before enrollment. Patients deemed unsuitable for the study by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "History of vaccination within 4 weeks before enrollment.",
                    "criterion": "vaccination history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients deemed unsuitable for the study by the investigator.",
                    "criterion": "suitability for the study",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "deemed unsuitable by the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}