{
"info": {
"nct_id": "NCT06679673",
"official_title": "An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.",
"inclusion_criteria": "* 18-75 years;\n* Histological confirmed metastatic colorectal cancer;\n* ECOG PS 0-1;\n* At least one measurable lesion (according to RECIST1.1);\n* Adequate hepatic, renal, coagulation, and hematologic functions;\n* Agree to use contraception during the study and 3 months after the end of the study. Negative serum pregnancy test at screening for women of childbearing potential;\n* Patients voluntarily enroll in the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n* Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);\n* Allergy to the study drug or any of its excipients;\n* Prior treatment with immune checkpoint inhibitors;\n* Received the following treatments before the first study treatment;\n\n 1. Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).\n 2. Prior use of immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids) within 7 days before treatment;\n 3. Received immunomodulatory drugs within 3 weeks before treatment;\n 4. Received live attenuated vaccine within 28 days before treatment;\n 5. Receipt of other antitumor systemic therapy within 28 days prior to treatment;\n* Presence of any active autoimmune disease or history of autoimmune disease with expected relapse;\n* A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;\n* A history of interstitial lung disease or non-infectious pneumonia, etc.;\n* Within 6 months before enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; hypertension with poorly controlled by medications;\n* A history of severe bleeding within 3 months (>30 ml at a time) or hemoptysis within 1 month (>5 ml at a time) or a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months;\n* Surgical treatment (except biopsy) within 6 weeks or unhealed surgical incision;\n* Long-standing unhealed wounds or fractures that have not healed properly\n* Imaging showing that the tumor has invaded a vital vascular perimeter or if, in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel and causing a fatal hemorrhage during therapy\n* A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months before the first study treatment\n* Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;\n* Unable to take the drug orally, or has a condition judged by the investigator to affect the absorption of the drug;\n* Pregnancy, lactation, and unwillingness of reproductively active subjects to use effective contraception;\n* Other conditions deemed by the investigator to be ineligible for inclusion in the study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* 18-75 years;",
"criterions": [
{
"exact_snippets": "18-75 years",
"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",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histological confirmed metastatic colorectal cancer;",
"criterions": [
{
"exact_snippets": "Histological confirmed metastatic colorectal cancer",
"criterion": "metastatic colorectal cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histological"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histological confirmed metastatic colorectal cancer",
"criterion": "metastatic colorectal cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histological"
}
}
]
}
},
{
"identified_line": {
"line": "* ECOG PS 0-1;",
"criterions": [
{
"exact_snippets": "ECOG PS 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG PS 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* At least one measurable lesion (according to RECIST1.1);",
"criterions": [
{
"exact_snippets": "At least one measurable lesion (according to RECIST1.1)",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least one measurable lesion (according to RECIST1.1)",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hepatic, renal, coagulation, and hematologic functions;",
"criterions": [
{
"exact_snippets": "Adequate hepatic ... functions",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal ... functions",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... coagulation ... functions",
"criterion": "coagulation function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hematologic functions",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hepatic ... functions",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal ... functions",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... coagulation ... functions",
"criterion": "coagulation function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hematologic functions",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Agree to use contraception during the study and 3 months after the end of the study. Negative serum pregnancy test at screening for women of childbearing potential;",
"criterions": [
{
"exact_snippets": "Agree to use contraception during the study and 3 months after the end of the study.",
"criterion": "contraception use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "Negative serum pregnancy test at screening for women of childbearing potential",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Agree to use contraception during the study and 3 months after the end of the study.",
"criterion": "contraception use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "Negative serum pregnancy test at screening for women of childbearing potential",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);",
"criterions": [
{
"exact_snippets": "Symptomatic brain or meningeal metastases",
"criterion": "brain or meningeal metastases",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
},
{
"exact_snippets": "BMS disease is stable for at least 4 weeks",
"criterion": "BMS disease stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Symptomatic brain or meningeal metastases",
"criterion": "brain or meningeal metastases",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "BMS disease is stable for at least 4 weeks",
"criterion": "BMS disease stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Prior treatment with immune checkpoint inhibitors;",
"criterions": [
{
"exact_snippets": "Prior treatment with immune checkpoint inhibitors",
"criterion": "immune checkpoint inhibitors",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior treatment with immune checkpoint inhibitors",
"criterion": "immune checkpoint inhibitors",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Received the following treatments before the first study treatment;",
"criterions": [
{
"exact_snippets": "Received the following treatments before the first study treatment",
"criterion": "prior treatments",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Received the following treatments before the first study treatment",
"criterion": "prior treatments",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "1. Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).",
"criterions": [
{
"exact_snippets": "Major surgery within 28 days before treatment",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
},
{
"exact_snippets": "tissue biopsy for diagnostic purposes is permitted",
"criterion": "tissue biopsy for diagnostic purposes",
"requirement": {
"requirement_type": "permitted",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Major surgery within 28 days before treatment",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
},
{
"exact_snippets": "tissue biopsy for diagnostic purposes is permitted",
"criterion": "tissue biopsy for diagnostic purposes",
"requirement": {
"requirement_type": "permitted",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients voluntarily enroll in the study.",
"criterions": [
{
"exact_snippets": "Patients voluntarily enroll",
"criterion": "voluntary enrollment",
"requirement": {
"requirement_type": "participation",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"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": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"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": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"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": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);",
"criterions": [
{
"exact_snippets": "other malignant tumors within 5 years",
"criterion": "other malignant tumors",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
},
{
"exact_snippets": "cured basal cell carcinoma of the skin",
"criterion": "cured basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "carcinoma in situ of the cervix",
"criterion": "carcinoma in situ of the cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "2. Prior use of immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids) within 7 days before treatment;",
"criterions": [
{
"exact_snippets": "Prior use of immunosuppressive medications",
"criterion": "immunosuppressive medication use",
"requirement": {
"requirement_type": "prior use",
"expected_value": true
}
},
{
"exact_snippets": "excluding nasal and inhaled corticosteroids",
"criterion": "nasal and inhaled corticosteroids use",
"requirement": {
"requirement_type": "prior use",
"expected_value": false
}
},
{
"exact_snippets": "excluding ... physiologic doses of systemic steroids",
"criterion": "physiologic doses of systemic steroids use",
"requirement": {
"requirement_type": "prior use",
"expected_value": false
}
},
{
"exact_snippets": "no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids",
"criterion": "systemic steroid dose",
"requirement": {
"requirement_type": "dose",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "mg/d"
}
}
},
{
"exact_snippets": "within 7 days before treatment",
"criterion": "time since last immunosuppressive medication use",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "3. Received immunomodulatory drugs within 3 weeks before treatment;",
"criterions": [
{
"exact_snippets": "Received immunomodulatory drugs within 3 weeks before treatment",
"criterion": "immunomodulatory drugs",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "4. Received live attenuated vaccine within 28 days before treatment;",
"criterions": [
{
"exact_snippets": "Received live attenuated vaccine within 28 days before treatment",
"criterion": "live attenuated vaccine",
"requirement": {
"requirement_type": "time since administration",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "5. Receipt of other antitumor systemic therapy within 28 days prior to treatment;",
"criterions": [
{
"exact_snippets": "Receipt of other antitumor systemic therapy within 28 days prior to treatment",
"criterion": "receipt of other antitumor systemic therapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Presence of any active autoimmune disease or history of autoimmune disease with expected relapse;",
"criterions": [
{
"exact_snippets": "Presence of any active autoimmune disease",
"criterion": "active autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of autoimmune disease with expected relapse",
"criterion": "autoimmune disease with expected relapse",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation",
"criterions": [
{
"exact_snippets": "A known history of allogeneic organ transplantation",
"criterion": "allogeneic organ transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "A known history of ... allogeneic hematopoietic stem cell transplantation",
"criterion": "allogeneic hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;",
"criterions": [
{
"exact_snippets": "Human immunodeficiency virus (HIV) infection or known AIDS",
"criterion": "HIV infection or AIDS",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "untreated active hepatitis",
"criterion": "active hepatitis",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "HBV-DNA ≥ 2500 IU/ml",
"criterion": "HBV-DNA level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2500,
"unit": "IU/ml"
}
}
},
{
"exact_snippets": "abnormal liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "normality",
"expected_value": false
}
},
{
"exact_snippets": "hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "co-infection with hepatitis B and hepatitis C",
"criterion": "co-infection with hepatitis B and hepatitis C",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* A history of interstitial lung disease or non-infectious pneumonia, etc.;",
"criterions": [
{
"exact_snippets": "A history of interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "A history of ... non-infectious pneumonia",
"criterion": "non-infectious pneumonia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Within 6 months before enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; hypertension with poorly controlled by medications;",
"criterions": [
{
"exact_snippets": "myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "severe/unstable angina",
"criterion": "severe/unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "NYHA class 2 or greater cardiac insufficiency",
"criterion": "NYHA class 2 or greater cardiac insufficiency",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NYHA class"
}
}
},
{
"exact_snippets": "clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention",
"criterion": "clinically significant supraventricular or ventricular arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "hypertension with poorly controlled by medications",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled by medications"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* A history of severe bleeding within 3 months (>30 ml at a time) or hemoptysis within 1 month (>5 ml at a time) or a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months;",
"criterions": [
{
"exact_snippets": "A history of severe bleeding within 3 months (>30 ml at a time)",
"criterion": "severe bleeding",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "A history of severe bleeding within 3 months (>30 ml at a time)",
"criterion": "severe bleeding",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "A history of severe bleeding within 3 months (>30 ml at a time)",
"criterion": "severe bleeding",
"requirement": {
"requirement_type": "volume",
"expected_value": {
"operator": ">",
"value": 30,
"unit": "ml"
}
}
},
{
"exact_snippets": "hemoptysis within 1 month (>5 ml at a time)",
"criterion": "hemoptysis",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
},
{
"exact_snippets": "hemoptysis within 1 month (>5 ml at a time)",
"criterion": "hemoptysis",
"requirement": {
"requirement_type": "volume",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "ml"
}
}
},
{
"exact_snippets": "a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months",
"criterion": "thromboembolic event",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Surgical treatment (except biopsy) within 6 weeks or unhealed surgical incision;",
"criterions": [
{
"exact_snippets": "Surgical treatment (except biopsy) within 6 weeks",
"criterion": "surgical treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "weeks"
}
}
},
{
"exact_snippets": "unhealed surgical incision",
"criterion": "surgical incision",
"requirement": {
"requirement_type": "healing status",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Long-standing unhealed wounds or fractures that have not healed properly",
"criterions": [
{
"exact_snippets": "Long-standing unhealed wounds",
"criterion": "wounds",
"requirement": {
"requirement_type": "healing status",
"expected_value": "unhealed"
}
},
{
"exact_snippets": "Long-standing unhealed wounds",
"criterion": "wounds",
"requirement": {
"requirement_type": "duration",
"expected_value": "long-standing"
}
},
{
"exact_snippets": "fractures that have not healed properly",
"criterion": "fractures",
"requirement": {
"requirement_type": "healing status",
"expected_value": "not healed properly"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Imaging showing that the tumor has invaded a vital vascular perimeter or if, in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel and causing a fatal hemorrhage during therapy",
"criterions": [
{
"exact_snippets": "Imaging showing that the tumor has invaded a vital vascular perimeter",
"criterion": "tumor invasion of vascular perimeter",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel",
"criterion": "likelihood of tumor invading vital blood vessel",
"requirement": {
"requirement_type": "likelihood",
"expected_value": "very high"
}
},
{
"exact_snippets": "causing a fatal hemorrhage during therapy",
"criterion": "risk of fatal hemorrhage during therapy",
"requirement": {
"requirement_type": "risk",
"expected_value": "fatal"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months before the first study treatment",
"criterions": [
{
"exact_snippets": "A history of abdominal fistula",
"criterion": "abdominal fistula",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "A history of ... gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "A history of ... intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "A history of ... active gastrointestinal bleeding within 6 months before the first study treatment",
"criterion": "active gastrointestinal bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "A history of ... active gastrointestinal bleeding within 6 months before the first study treatment",
"criterion": "active gastrointestinal bleeding",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 6 months before the first study treatment"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;",
"criterions": [
{
"exact_snippets": "Urine routine showed urine protein ≥2+",
"criterion": "urine protein level (routine)",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "+"
}
}
},
{
"exact_snippets": "24-hour urine protein level >1.0g",
"criterion": "24-hour urine protein level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1.0,
"unit": "g"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Unable to take the drug orally, or has a condition judged by the investigator to affect the absorption of the drug;",
"criterions": [
{
"exact_snippets": "Unable to take the drug orally",
"criterion": "oral drug administration",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "condition judged by the investigator to affect the absorption of the drug",
"criterion": "condition affecting drug absorption",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pregnancy, lactation, and unwillingness of reproductively active subjects to use effective contraception;",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "unwillingness of reproductively active subjects to use effective contraception",
"criterion": "use of effective contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Other conditions deemed by the investigator to be ineligible for inclusion in the study.",
"criterions": [
{
"exact_snippets": "Other conditions deemed by the investigator to be ineligible",
"criterion": "other conditions",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "deemed ineligible by the investigator"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Allergy to the study drug or any of its excipients;",
"criterions": [
{
"exact_snippets": "Allergy to the study drug",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "allergy to ... any of its excipients",
"criterion": "allergy to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}