{
"info": {
"nct_id": "NCT05314101",
"official_title": "TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial",
"inclusion_criteria": "* Patients who provided informed consent and voluntarily enrolled\n* Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;\n* 18-75 years old;\n* Measurable target lesions according to RECIST V1.1 assessment criteria;\n* Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);\n* 0 ~ 2 points according to ECOG quality of life score;\n* Drugs can be taken orally\n* Estimated survival ≥3 months;\n* Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;\n* Ascites with no obvious symptoms and no clinical intervention;\n* Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;\n* Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Previous application of TAS-102;\n* Pregnant or lactating women;\n* No contraception during the reproductive period;\n* patients known to have a history of allergy to any study drug, similar drug or excipient;\n* Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;\n* Patients with a history of thromboembolism, except those caused by PICC;\n* Patients with active infection;\n* Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);\n* Patients with brain metastases with clinical symptoms or imaging evidence;\n* Contraindications for treatment of other chronic diseases;\n* Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2;\n* According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions;\n* Other conditions that the investigator determines are not suitable for inclusion in the study.\n* Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients who provided informed consent and voluntarily enrolled",
"criterions": [
{
"exact_snippets": "Patients who provided informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "voluntarily enrolled",
"criterion": "voluntary enrollment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who provided informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "voluntarily enrolled",
"criterion": "voluntary enrollment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;",
"criterions": [
{
"exact_snippets": "liver metastasis",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "advanced colorectal adenocarcinoma",
"criterion": "advanced colorectal adenocarcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "MSS confirmed by pathology",
"criterion": "MSS (microsatellite stability)",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathology"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "liver metastasis",
"criterion": "liver metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "advanced colorectal adenocarcinoma",
"criterion": "advanced colorectal adenocarcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "MSS confirmed by pathology",
"criterion": "MSS (microsatellite stability)",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathology"
}
}
]
}
},
{
"identified_line": {
"line": "* 18-75 years old;",
"criterions": [
{
"exact_snippets": "18-75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "18-75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Measurable target lesions according to RECIST V1.1 assessment criteria;",
"criterions": [
{
"exact_snippets": "Measurable target lesions according to RECIST V1.1 assessment criteria",
"criterion": "target lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": "according to RECIST V1.1 assessment criteria"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Measurable target lesions according to RECIST V1.1 assessment criteria",
"criterion": "target lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": "according to RECIST V1.1 assessment criteria"
}
}
]
}
},
{
"identified_line": {
"line": "* Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);",
"criterions": [
{
"exact_snippets": "Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil)",
"criterion": "progression after second-line treatment",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"irinotecan",
"oxaliplatin",
"fluorouracil"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil)",
"criterion": "progression after second-line treatment",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"irinotecan",
"oxaliplatin",
"fluorouracil"
]
}
}
]
}
},
{
"identified_line": {
"line": "* 0 ~ 2 points according to ECOG quality of life score;",
"criterions": [
{
"exact_snippets": "0 ~ 2 points according to ECOG quality of life score",
"criterion": "ECOG quality of life score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "points"
},
{
"operator": "<=",
"value": 2,
"unit": "points"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "0 ~ 2 points according to ECOG quality of life score",
"criterion": "ECOG quality of life score",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "points"
},
{
"operator": "<=",
"value": 2,
"unit": "points"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Drugs can be taken orally",
"criterions": [
{
"exact_snippets": "Drugs can be taken orally",
"criterion": "drug administration route",
"requirement": {
"requirement_type": "method",
"expected_value": "oral"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Drugs can be taken orally",
"criterion": "drug administration route",
"requirement": {
"requirement_type": "method",
"expected_value": "oral"
}
}
]
}
},
{
"identified_line": {
"line": "* Estimated survival ≥3 months;",
"criterions": [
{
"exact_snippets": "Estimated survival ≥3 months",
"criterion": "estimated survival",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Estimated survival ≥3 months",
"criterion": "estimated survival",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;",
"criterions": [
{
"exact_snippets": "Women of childbearing age",
"criterion": "gender and reproductive status",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "Women of childbearing age",
"criterion": "gender and reproductive status",
"requirement": {
"requirement_type": "reproductive status",
"expected_value": "childbearing age"
}
},
{
"exact_snippets": "pregnancy test is negative",
"criterion": "pregnancy test result",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Women of childbearing age",
"criterion": "gender and reproductive status",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "Women of childbearing age",
"criterion": "gender and reproductive status",
"requirement": {
"requirement_type": "reproductive status",
"expected_value": "childbearing age"
}
}
]
},
{
"exact_snippets": "pregnancy test is negative",
"criterion": "pregnancy test result",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"then_criteria": {
"exact_snippets": "Women of childbearing age should comply with contraceptive measures",
"criterion": "contraceptive measures compliance",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Ascites with no obvious symptoms and no clinical intervention;",
"criterions": [
{
"exact_snippets": "Ascites",
"criterion": "ascites",
"requirement": {
"requirement_type": "symptoms",
"expected_value": "no obvious symptoms"
}
},
{
"exact_snippets": "Ascites",
"criterion": "ascites",
"requirement": {
"requirement_type": "clinical intervention",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ascites",
"criterion": "ascites",
"requirement": {
"requirement_type": "symptoms",
"expected_value": "no obvious symptoms"
}
},
{
"exact_snippets": "Ascites",
"criterion": "ascites",
"requirement": {
"requirement_type": "clinical intervention",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.",
"criterions": [
{
"exact_snippets": "Adherence to scheduled visits",
"criterion": "adherence to scheduled visits",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
},
{
"exact_snippets": "Adherence to ... treatment plans",
"criterion": "adherence to treatment plans",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
},
{
"exact_snippets": "Adherence to ... laboratory tests",
"criterion": "adherence to laboratory tests",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
},
{
"exact_snippets": "Adherence to ... other study procedures",
"criterion": "adherence to other study procedures",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability",
"criterion": "willingness and ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adherence to scheduled visits",
"criterion": "adherence to scheduled visits",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
},
{
"exact_snippets": "Adherence to ... treatment plans",
"criterion": "adherence to treatment plans",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Adherence to ... laboratory tests",
"criterion": "adherence to laboratory tests",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Adherence to ... other study procedures",
"criterion": "adherence to other study procedures",
"requirement": {
"requirement_type": "adherence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability",
"criterion": "willingness and ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Previous application of TAS-102;",
"criterions": [
{
"exact_snippets": "Previous application of TAS-102",
"criterion": "TAS-102 application",
"requirement": {
"requirement_type": "previous application",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Previous application of TAS-102",
"criterion": "TAS-102 application",
"requirement": {
"requirement_type": "previous application",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant or lactating women;",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* No contraception during the reproductive period;",
"criterions": [
{
"exact_snippets": "No contraception during the reproductive period",
"criterion": "contraception",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No contraception during the reproductive period",
"criterion": "contraception",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* patients known to have a history of allergy to any study drug, similar drug or excipient;",
"criterions": [
{
"exact_snippets": "patients known to have a history of allergy to any study drug",
"criterion": "allergy to study drug",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "patients known to have a history of allergy to any ... similar drug",
"criterion": "allergy to similar drug",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "patients known to have a history of allergy to any ... excipient",
"criterion": "allergy to excipient",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "patients known to have a history of allergy to any study drug",
"criterion": "allergy to study drug",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "patients known to have a history of allergy to any ... similar drug",
"criterion": "allergy to similar drug",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "patients known to have a history of allergy to any ... excipient",
"criterion": "allergy to excipient",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with a history of thromboembolism, except those caused by PICC;",
"criterions": [
{
"exact_snippets": "history of thromboembolism",
"criterion": "thromboembolism",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "except those caused by PICC",
"criterion": "thromboembolism caused by PICC",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "history of thromboembolism",
"criterion": "thromboembolism",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
"then_criteria": {
"not_criteria": {
"exact_snippets": "except those caused by PICC",
"criterion": "thromboembolism caused by PICC",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Patients with active infection;",
"criterions": [
{
"exact_snippets": "Patients with active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients with active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);",
"criterions": [
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "systolic blood pressure ≥160 mmHg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 160,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "diastolic blood pressure ≥90) MmHg",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "mmHg"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "systolic blood pressure ≥160 mmHg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 160,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "diastolic blood pressure ≥90) MmHg",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "mmHg"
}
}
}
]
},
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.",
"criterions": [
{
"exact_snippets": "Received any anti-tumor therapy",
"criterion": "anti-tumor therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "participated in other clinical studies within 4 weeks prior to enrollment",
"criterion": "participation in other clinical studies",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Received any anti-tumor therapy",
"criterion": "anti-tumor therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "participated in other clinical studies within 4 weeks prior to enrollment",
"criterion": "participation in other clinical studies",
"requirement": {
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;",
"criterions": [
{
"exact_snippets": "Adequate organ and bone marrow functions",
"criterion": "organ and bone marrow functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "ecg",
"criterion": "ECG",
"requirement": {
"requirement_type": "contraindication",
"expected_value": false
}
},
{
"exact_snippets": "blood",
"criterion": "blood tests",
"requirement": {
"requirement_type": "contraindication",
"expected_value": false
}
},
{
"exact_snippets": "biochemical",
"criterion": "biochemical tests",
"requirement": {
"requirement_type": "contraindication",
"expected_value": false
}
},
{
"exact_snippets": "other basic tests",
"criterion": "other basic tests",
"requirement": {
"requirement_type": "contraindication",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate organ and bone marrow functions",
"criterion": "organ and bone marrow functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "ecg",
"criterion": "ECG",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "blood",
"criterion": "blood tests",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "biochemical",
"criterion": "biochemical tests",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "other basic tests",
"criterion": "other basic tests",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;",
"criterions": [
{
"exact_snippets": "risk of massive gastrointestinal bleeding",
"criterion": "risk of massive gastrointestinal bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "risk of ... gastrointestinal obstruction",
"criterion": "risk of gastrointestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "risk of massive gastrointestinal bleeding",
"criterion": "risk of massive gastrointestinal bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "risk of ... gastrointestinal obstruction",
"criterion": "risk of gastrointestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with brain metastases with clinical symptoms or imaging evidence;",
"criterions": [
{
"exact_snippets": "brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinical symptoms",
"criterion": "clinical symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "imaging evidence",
"criterion": "imaging evidence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Contraindications for treatment of other chronic diseases;",
"criterions": [
{
"exact_snippets": "Contraindications for treatment of other chronic diseases",
"criterion": "contraindications for treatment",
"requirement": {
"requirement_type": "condition",
"expected_value": "other chronic diseases"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2;",
"criterions": [
{
"exact_snippets": "Previous immunotherapy-related myocarditis",
"criterion": "immunotherapy-related myocarditis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Previous immunotherapy-related ... pneumonia",
"criterion": "immunotherapy-related pneumonia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Previous immunotherapy-related ... colitis",
"criterion": "immunotherapy-related colitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Previous immunotherapy-related ... hepatitis",
"criterion": "immunotherapy-related hepatitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Previous immunotherapy-related ... kidney Inflammation",
"criterion": "immunotherapy-related kidney inflammation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "the current AE is still ≥2",
"criterion": "current adverse event (AE) grade",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions;",
"criterions": [
{
"exact_snippets": "Patients with grade ≥2 toxic reactions",
"criterion": "toxic reactions",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "grade"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Other conditions that the investigator determines are not suitable for inclusion in the study.",
"criterions": [
{
"exact_snippets": "Other conditions that the investigator determines are not suitable for inclusion in the study.",
"criterion": "other conditions",
"requirement": {
"requirement_type": "suitability for inclusion",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}