{
    "info": {
        "nct_id": "NCT04226066",
        "official_title": "A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors",
        "inclusion_criteria": "1. Male or female, aged ≥18 years and ≤ 75;\n2. Part1-Part3: histological or cytological confirmed advanced malignant solid tumors patients who have received standard therapeutic options in previous treatment and now there's no standard therapy available; Part4: patients with gastric cancer, pancreatic cancer and hepatocellular carcinoma will be enrolled in Phase IIa Clinical Trial;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n4. Expected survival of at least 3 months;\n5. Patient presenting with at least one evaluable lesion according to RECIST 1.1 in Part1-Part3; patient presenting with at least one measurable lesion according to RECIST 1.1 in Part4;\n6. Adequate blood system function, liver function and kidney function:\n\n   1. ANC≥1.5×109/L，PLT≥80×109/L，Hb≥90 g/L;\n   2. TBIL≤1.5×ULN，ALT≤3×ULN，AST≤3×ULN (Patients with liver metastasis or liver cancer ALT≤5×ULN，AST≤5×ULN);\n   3. Cr≤1.5×ULN, creatinine clearance>50mL/min (calculate according to Cockcroft-Gault Formula);\n   4. APTT≤1.5×ULN，PT≤1.5×ULN，INR≤1.5×ULN.\n7. Fertile eligible patients (male and female) must agree to use highly effective method of contraception (i.e. hormone or barrier method or abstinence) during clinical trial and for a minimum of 12 weeks after the last administration of T601; negative blood pregnancy test for women of childbearing potential (WOCBP) within 7 days before enrollment ;\n8. Give informed consent to the study prior to the test and voluntarily sign a written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Received chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to T601 treatment initiation, except for the following items:\n\n   Received nitrosourea or mitomycin C within 6 weeks before T601 treatment initiation; Orally taken fluorouracil and small-molecule targeted drugs within 2 weeks before T601 treatment initiation or within 5 half-lives of the above drugs (subject to whichever is longer); Received the Chinese medicines with anti-tumor indications within 2 weeks before T601 treatment initiation;\n2. Prior participation in another clinical study involving an IMP with last intake within 4 weeks prior to T601 treatment initiation;\n3. Received major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks prior to T601 treatment initiation;\n4. The adverse reactions of previous anti-tumor therapy have not yet returned to CTCAE 5.0 ≤1 (except the toxicity that the investigator judged as no safety risk, such as hair loss);\n5. With clinical symptoms of brain metastasis, spinal cord compression, and cancerous meningitis, or other evidence indicates that the metastasis of the patient's brain and spinal cord has not been controlled, and the investigator judged that the patient was not suitable for inclusion. Patients with clinical symptoms suspected of cerebral or pia mater disease should be excluded by CT/MRI examination;\n6. Uncontrolled bacterial, viral or fungal infections requiring systematic treatment;\n7. History of immunodeficiency, including positive HIV antibody test;\n8. Active chronic hepatitis B (HBV-DNA higher than the lower limit of detection), hepatitis C antibody positive;\n9. Patients who are unable to swallow oral drugs;\n10. History of serious cardiovascular and cerebrovascular diseases:\n\n    1. Ventricular arrhythmias requiring clinical intervention;\n    2. Acute coronary syndrome, congestive heart failure, stroke or other class III or above cardiovascular events within 6 months;\n    3. New York Heart Association (NYHA) cardiac function grade ≥II or Left Ventricular Ejection Fraction (LVEF) <50%;\n    4. Hypertension uncontrolled by standard treatment;\n11. Skin diseases that need systematic treatment;\n12. Patients who need long-term use of glucocorticoids (prednisone>10 mg/d or equivalent dose of the same drug) or other immunosuppressive agents during the study period or within 14 days before initiation of T601; Exceptions: local, ocular, intra-articular, intranasal, and inhaled glucocorticoid therapy; Short-term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);\n13. History of severe systemic reaction or side-effect after vaccinia vaccine injection;\n14. Known hypersensitivity to 5-FC or intolerance to 5-FC treatment;\n15. Known alcohol or drug dependence;\n16. Mental disorders or patients unable or unwilling to comply with the protocol requirements;\n17. Pregnant or lactating female patients;\n18. Patients who, as determined by the investigator, have other serious systemic diseases or laboratory abnormalities or other reasons, are not eligible to participate in this clinical trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female, aged ≥18 years and ≤ 75;",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years and ≤ 75",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Part1-Part3: histological or cytological confirmed advanced malignant solid tumors patients who have received standard therapeutic options in previous treatment and now there's no standard therapy available; Part4: patients with gastric cancer, pancreatic cancer and hepatocellular carcinoma will be enrolled in Phase IIa Clinical Trial;",
            "criterions": [
                {
                    "exact_snippets": "histological or cytological confirmed advanced malignant solid tumors",
                    "criterion": "advanced malignant solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have received standard therapeutic options in previous treatment",
                    "criterion": "standard therapeutic options",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "now there's no standard therapy available",
                    "criterion": "standard therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with gastric cancer, pancreatic cancer and hepatocellular carcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric cancer",
                                "pancreatic cancer",
                                "hepatocellular carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;",
            "criterions": [
                {
                    "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": "4. Expected survival of at least 3 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival of at least 3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patient presenting with at least one evaluable lesion according to RECIST 1.1 in Part1-Part3; patient presenting with at least one measurable lesion according to RECIST 1.1 in Part4;",
            "criterions": [
                {
                    "exact_snippets": "Patient presenting with at least one evaluable lesion according to RECIST 1.1 in Part1-Part3",
                    "criterion": "evaluable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patient presenting with at least one measurable lesion according to RECIST 1.1 in Part4",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate blood system function, liver function and kidney function:",
            "criterions": [
                {
                    "exact_snippets": "Adequate blood system function",
                    "criterion": "blood system function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... kidney function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ANC≥1.5×109/L，PLT≥80×109/L，Hb≥90 g/L;",
            "criterions": [
                {
                    "exact_snippets": "ANC≥1.5×109/L",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PLT≥80×109/L",
                    "criterion": "PLT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hb≥90 g/L",
                    "criterion": "Hb",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. TBIL≤1.5×ULN，ALT≤3×ULN，AST≤3×ULN (Patients with liver metastasis or liver cancer ALT≤5×ULN，AST≤5×ULN);",
            "criterions": [
                {
                    "exact_snippets": "TBIL≤1.5×ULN",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT≤3×ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST≤3×ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with liver metastasis or liver cancer ALT≤5×ULN",
                    "criterion": "alanine aminotransferase (ALT) in patients with liver metastasis or liver cancer",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with liver metastasis or liver cancer ... AST≤5×ULN",
                    "criterion": "aspartate aminotransferase (AST) in patients with liver metastasis or liver cancer",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Cr≤1.5×ULN, creatinine clearance>50mL/min (calculate according to Cockcroft-Gault Formula);",
            "criterions": [
                {
                    "exact_snippets": "Cr≤1.5×ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance>50mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. APTT≤1.5×ULN，PT≤1.5×ULN，INR≤1.5×ULN.",
            "criterions": [
                {
                    "exact_snippets": "APTT≤1.5×ULN",
                    "criterion": "APTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT≤1.5×ULN",
                    "criterion": "PT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "INR≤1.5×ULN",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Fertile eligible patients (male and female) must agree to use highly effective method of contraception (i.e. hormone or barrier method or abstinence) during clinical trial and for a minimum of 12 weeks after the last administration of T601; negative blood pregnancy test for women of childbearing potential (WOCBP) within 7 days before enrollment ;",
            "criterions": [
                {
                    "exact_snippets": "Fertile eligible patients (male and female) must agree to use highly effective method of contraception",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "highly effective method of contraception (i.e. hormone or barrier method or abstinence)",
                    "criterion": "method of contraception",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormone",
                                "barrier method",
                                "abstinence"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "during clinical trial and for a minimum of 12 weeks after the last administration of T601",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during clinical trial and for a minimum of 12 weeks after the last administration of T601"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative blood pregnancy test for women of childbearing potential (WOCBP) within 7 days before enrollment",
                    "criterion": "blood pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Give informed consent to the study prior to the test and voluntarily sign a written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Give informed consent to the study ... voluntarily sign a written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Received chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to T601 treatment initiation, except for the following items:",
            "criterions": [
                {
                    "exact_snippets": "Received chemotherapy ... within 4 weeks prior to T601 treatment initiation",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... radiation ... within 4 weeks prior to T601 treatment initiation",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... biotherapy ... within 4 weeks prior to T601 treatment initiation",
                    "criterion": "biotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... endocrine therapy ... within 4 weeks prior to T601 treatment initiation",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... immunotherapy ... within 4 weeks prior to T601 treatment initiation",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... other anti-tumor treatments within 4 weeks prior to T601 treatment initiation",
                    "criterion": "other anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Received nitrosourea or mitomycin C within 6 weeks before T601 treatment initiation; Orally taken fluorouracil and small-molecule targeted drugs within 2 weeks before T601 treatment initiation or within 5 half-lives of the above drugs (subject to whichever is longer); Received the Chinese medicines with anti-tumor indications within 2 weeks before T601 treatment initiation;",
            "criterions": [
                {
                    "exact_snippets": "Received nitrosourea or mitomycin C within 6 weeks before T601 treatment initiation",
                    "criterion": "nitrosourea or mitomycin C treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Orally taken fluorouracil and small-molecule targeted drugs within 2 weeks before T601 treatment initiation or within 5 half-lives of the above drugs (subject to whichever is longer)",
                    "criterion": "fluorouracil and small-molecule targeted drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "within 2 weeks or 5 half-lives, whichever is longer"
                        }
                    ]
                },
                {
                    "exact_snippets": "Received the Chinese medicines with anti-tumor indications within 2 weeks before T601 treatment initiation",
                    "criterion": "Chinese medicines with anti-tumor indications",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior participation in another clinical study involving an IMP with last intake within 4 weeks prior to T601 treatment initiation;",
            "criterions": [
                {
                    "exact_snippets": "Prior participation in another clinical study",
                    "criterion": "prior clinical study participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "involving an IMP",
                    "criterion": "IMP involvement in prior study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "last intake within 4 weeks prior to T601 treatment initiation",
                    "criterion": "time since last IMP intake",
                    "requirements": [
                        {
                            "requirement_type": "time since last intake",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Received major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks prior to T601 treatment initiation;",
            "criterions": [
                {
                    "exact_snippets": "Received major organ surgery (excluding needle biopsy) ... within 4 weeks prior to T601 treatment initiation",
                    "criterion": "major organ surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... severe trauma within 4 weeks prior to T601 treatment initiation",
                    "criterion": "severe trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since trauma",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The adverse reactions of previous anti-tumor therapy have not yet returned to CTCAE 5.0 ≤1 (except the toxicity that the investigator judged as no safety risk, such as hair loss);",
            "criterions": [
                {
                    "exact_snippets": "adverse reactions of previous anti-tumor therapy have not yet returned to CTCAE 5.0 ≤1",
                    "criterion": "adverse reactions of previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "CTCAE 5.0"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicity that the investigator judged as no safety risk, such as hair loss",
                    "criterion": "toxicity",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. With clinical symptoms of brain metastasis, spinal cord compression, and cancerous meningitis, or other evidence indicates that the metastasis of the patient's brain and spinal cord has not been controlled, and the investigator judged that the patient was not suitable for inclusion. Patients with clinical symptoms suspected of cerebral or pia mater disease should be excluded by CT/MRI examination;",
            "criterions": [
                {
                    "exact_snippets": "clinical symptoms of brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms of ... spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms of ... cancerous meningitis",
                    "criterion": "cancerous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence indicates that the metastasis of the patient's brain and spinal cord has not been controlled",
                    "criterion": "uncontrolled brain and spinal cord metastasis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms suspected of cerebral or pia mater disease",
                    "criterion": "cerebral or pia mater disease",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "should be excluded by CT/MRI examination",
                    "criterion": "CT/MRI examination",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Uncontrolled bacterial, viral or fungal infections requiring systematic treatment;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled bacterial, viral or fungal infections",
                    "criterion": "bacterial, viral or fungal infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "infections requiring systematic treatment",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systematic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of immunodeficiency, including positive HIV antibody test;",
            "criterions": [
                {
                    "exact_snippets": "History of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive HIV antibody test",
                    "criterion": "HIV antibody test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Active chronic hepatitis B (HBV-DNA higher than the lower limit of detection), hepatitis C antibody positive;",
            "criterions": [
                {
                    "exact_snippets": "Active chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV-DNA higher than the lower limit of detection",
                    "criterion": "HBV-DNA",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower limit of detection"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C antibody positive",
                    "criterion": "hepatitis C antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients who are unable to swallow oral drugs;",
            "criterions": [
                {
                    "exact_snippets": "unable to swallow oral drugs",
                    "criterion": "ability to swallow oral drugs",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of serious cardiovascular and cerebrovascular diseases:",
            "criterions": [
                {
                    "exact_snippets": "History of serious cardiovascular ... diseases",
                    "criterion": "cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of serious ... cerebrovascular diseases",
                    "criterion": "cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Ventricular arrhythmias requiring clinical intervention;",
            "criterions": [
                {
                    "exact_snippets": "Ventricular arrhythmias requiring clinical intervention",
                    "criterion": "ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring clinical intervention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Acute coronary syndrome, congestive heart failure, stroke or other class III or above cardiovascular events within 6 months;",
            "criterions": [
                {
                    "exact_snippets": "Acute coronary syndrome",
                    "criterion": "acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "class III or above cardiovascular events",
                    "criterion": "class III or above cardiovascular events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months",
                    "criterion": "time since cardiovascular event",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. New York Heart Association (NYHA) cardiac function grade ≥II or Left Ventricular Ejection Fraction (LVEF) <50%;",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) cardiac function grade ≥II",
                    "criterion": "NYHA cardiac function grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) <50%",
                    "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Hypertension uncontrolled by standard treatment;",
            "criterions": [
                {
                    "exact_snippets": "Hypertension uncontrolled by standard treatment",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled by standard treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Skin diseases that need systematic treatment;",
            "criterions": [
                {
                    "exact_snippets": "Skin diseases that need systematic treatment",
                    "criterion": "skin diseases",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "systematic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients who need long-term use of glucocorticoids (prednisone>10 mg/d or equivalent dose of the same drug) or other immunosuppressive agents during the study period or within 14 days before initiation of T601; Exceptions: local, ocular, intra-articular, intranasal, and inhaled glucocorticoid therapy; Short-term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);",
            "criterions": [
                {
                    "exact_snippets": "long-term use of glucocorticoids (prednisone>10 mg/d or equivalent dose of the same drug)",
                    "criterion": "long-term glucocorticoid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/d"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive agents during the study period or within 14 days before initiation of T601",
                    "criterion": "use of immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of severe systemic reaction or side-effect after vaccinia vaccine injection;",
            "criterions": [
                {
                    "exact_snippets": "History of severe systemic reaction or side-effect after vaccinia vaccine injection",
                    "criterion": "severe systemic reaction or side-effect after vaccinia vaccine injection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Known hypersensitivity to 5-FC or intolerance to 5-FC treatment;",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to 5-FC",
                    "criterion": "hypersensitivity to 5-FC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance to 5-FC treatment",
                    "criterion": "intolerance to 5-FC treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Known alcohol or drug dependence;",
            "criterions": [
                {
                    "exact_snippets": "Known alcohol or drug dependence",
                    "criterion": "alcohol dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known alcohol or drug dependence",
                    "criterion": "drug dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Mental disorders or patients unable or unwilling to comply with the protocol requirements;",
            "criterions": [
                {
                    "exact_snippets": "Mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients unable or unwilling to comply with the protocol requirements",
                    "criterion": "compliance with protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Pregnant or lactating female patients;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating female patients",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Patients who, as determined by the investigator, have other serious systemic diseases or laboratory abnormalities or other reasons, are not eligible to participate in this clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "other serious systemic diseases",
                    "criterion": "serious systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other reasons",
                    "criterion": "other reasons",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}