{
"info": {
"nct_id": "NCT06288360",
"official_title": "Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial",
"inclusion_criteria": "1. FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size≥4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);\n2. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.\n3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;\n4. Negative PD-L1 expression on preoperative pathological examination (Combined positive score < 1);\n5. 18-70 years of age;\n6. Eastern Cooperative Oncology Group score ≤ 1;\n7. WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥100×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;\n8. Well-compliance and willing to keep in touch;\n9. Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "1. Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;\n2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;\n3. Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;\n4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;\n5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;\n6. Active systemic infection requiring systemic treatment;\n7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL), and patients with cured hepatitis C are eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;\n9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;\n10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);\n11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;\n12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;\n13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;\n14. Have received a prior allogeneic bone marrow transplant or solid organ transplant;\n15. History of primary malignant tumor within the last 5 years;\n16. Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;\n17. With a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;\n18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance/requiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;\n19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;\n20. Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;\n21. Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results. Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements are not permitted to participate in this study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "2. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.",
"criterions": [
{
"exact_snippets": "at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "size of the lesion as shown by the magnetic resonance imaging examination",
"criterion": "lesion size",
"requirement": {
"requirement_type": "measurement method",
"expected_value": "magnetic resonance imaging"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "size of the lesion as shown by the magnetic resonance imaging examination",
"criterion": "lesion size",
"requirement": {
"requirement_type": "measurement method",
"expected_value": "magnetic resonance imaging"
}
}
]
}
},
{
"identified_line": {
"line": "3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;",
"criterions": [
{
"exact_snippets": "Histologically confirmed squamous carcinoma ... of the cervix",
"criterion": "squamous carcinoma of the cervix",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "Histologically confirmed ... adenocarcinoma (common type) ... of the cervix",
"criterion": "adenocarcinoma of the cervix",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "Histologically confirmed ... adenosquamous carcinoma of the cervix",
"criterion": "adenosquamous carcinoma of the cervix",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed squamous carcinoma ... of the cervix",
"criterion": "squamous carcinoma of the cervix",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed ... adenocarcinoma (common type) ... of the cervix",
"criterion": "adenocarcinoma of the cervix",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed ... adenosquamous carcinoma of the cervix",
"criterion": "adenosquamous carcinoma of the cervix",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "4. Negative PD-L1 expression on preoperative pathological examination (Combined positive score < 1);",
"criterions": [
{
"exact_snippets": "Negative PD-L1 expression on preoperative pathological examination",
"criterion": "PD-L1 expression",
"requirement": {
"requirement_type": "expression",
"expected_value": "negative"
}
},
{
"exact_snippets": "Combined positive score < 1",
"criterion": "Combined positive score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Negative PD-L1 expression on preoperative pathological examination",
"criterion": "PD-L1 expression",
"requirement": {
"requirement_type": "expression",
"expected_value": "negative"
}
},
{
"exact_snippets": "Combined positive score < 1",
"criterion": "Combined positive score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "5. 18-70 years of age;",
"criterions": [
{
"exact_snippets": "18-70 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "18-70 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "6. Eastern Cooperative Oncology Group score ≤ 1;",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group score ≤ 1",
"criterion": "Eastern Cooperative Oncology Group score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group score ≤ 1",
"criterion": "Eastern Cooperative Oncology Group score",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "7. WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥100×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;",
"criterions": [
{
"exact_snippets": "WBC≥3.5*10^9/L",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3.5,
"unit": "*10^9/L"
}
}
},
{
"exact_snippets": "NEU≥1.5*10^9/L",
"criterion": "NEU",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "*10^9/L"
}
}
},
{
"exact_snippets": "Platelet≥100×10^9 /L",
"criterion": "Platelet",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9 /L"
}
}
},
{
"exact_snippets": "AST and ALT ≤1.5 times normal upper limit",
"criterion": "AST and ALT",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times normal upper limit"
}
}
},
{
"exact_snippets": "Total bilirubin ≤1.5 times the upper limit of normal value",
"criterion": "Total bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times the upper limit of normal value"
}
}
},
{
"exact_snippets": "serum creatinine and blood urea nitrogen ≤the upper limit of normal value",
"criterion": "serum creatinine and blood urea nitrogen",
"requirement": {
"requirement_type": "quantity",
"expected_value": "≤the upper limit of normal value"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "WBC≥3.5*10^9/L",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3.5,
"unit": "*10^9/L"
}
}
},
{
"exact_snippets": "NEU≥1.5*10^9/L",
"criterion": "NEU",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "*10^9/L"
}
}
},
{
"exact_snippets": "Platelet≥100×10^9 /L",
"criterion": "Platelet",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9 /L"
}
}
},
{
"exact_snippets": "AST and ALT ≤1.5 times normal upper limit",
"criterion": "AST and ALT",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times normal upper limit"
}
}
},
{
"exact_snippets": "Total bilirubin ≤1.5 times the upper limit of normal value",
"criterion": "Total bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times the upper limit of normal value"
}
}
},
{
"exact_snippets": "serum creatinine and blood urea nitrogen ≤the upper limit of normal value",
"criterion": "serum creatinine and blood urea nitrogen",
"requirement": {
"requirement_type": "quantity",
"expected_value": "≤the upper limit of normal value"
}
}
]
}
},
{
"identified_line": {
"line": "8. Well-compliance and willing to keep in touch;",
"criterions": [
{
"exact_snippets": "Well-compliance",
"criterion": "compliance",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willing to keep in touch",
"criterion": "willingness to maintain contact",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Well-compliance",
"criterion": "compliance",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willing to keep in touch",
"criterion": "willingness to maintain contact",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "9. Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.",
"criterions": [
{
"exact_snippets": "Willing to participate in this study",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "sign the informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form",
"criterion": "compliance with requirements and limitations",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Willing to participate in this study",
"criterion": "willingness to participate",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "sign the informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form",
"criterion": "compliance with requirements and limitations",
"requirement": {
"requirement_type": "compliance",
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"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 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;",
"criterions": [
{
"exact_snippets": "Active, known, or suspected autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of an autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years",
"criterion": "specific autoimmune diseases",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"vitiligo",
"alopecia areata",
"Graves's disease",
"psoriasis",
"eczema"
]
}
},
{
"exact_snippets": "hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis)",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "symptom presence",
"expected_value": false
}
},
{
"exact_snippets": "hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis)",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "treatment stability",
"expected_value": "stable doses of hormone replacement therapy"
}
},
{
"exact_snippets": "type 1 diabetes that requires only stable doses of insulin replacement therapy",
"criterion": "type 1 diabetes",
"requirement": {
"requirement_type": "treatment stability",
"expected_value": "stable doses of insulin replacement therapy"
}
},
{
"exact_snippets": "asthma that subsides completely in childhood and does not require intervention in adulthood",
"criterion": "asthma",
"requirement": {
"requirement_type": "symptom presence",
"expected_value": false
}
},
{
"exact_snippets": "diseases that do not recur in the absence of external triggers",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "recurrence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Active, known, or suspected autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of an autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
}
]
},
{
"not_criteria": {
"exact_snippets": "vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years",
"criterion": "specific autoimmune diseases",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"vitiligo",
"alopecia areata",
"Graves's disease",
"psoriasis",
"eczema"
]
}
}
},
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis)",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "symptom presence",
"expected_value": false
}
},
{
"exact_snippets": "hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis)",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "treatment stability",
"expected_value": "stable doses of hormone replacement therapy"
}
}
]
}
},
{
"not_criteria": {
"exact_snippets": "type 1 diabetes that requires only stable doses of insulin replacement therapy",
"criterion": "type 1 diabetes",
"requirement": {
"requirement_type": "treatment stability",
"expected_value": "stable doses of insulin replacement therapy"
}
}
},
{
"not_criteria": {
"exact_snippets": "asthma that subsides completely in childhood and does not require intervention in adulthood",
"criterion": "asthma",
"requirement": {
"requirement_type": "symptom presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "diseases that do not recur in the absence of external triggers",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "recurrence",
"expected_value": false
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;",
"criterions": [
{
"exact_snippets": "Prior treatment with immune checkpoint inhibitors",
"criterion": "prior treatment with immune checkpoint inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other anti-PD-1, anti-PD-L1 antibodies",
"criterion": "prior treatment with anti-PD-1 or anti-PD-L1 antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "CTLA-4 antibodies",
"criterion": "prior treatment with CTLA-4 antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.)",
"criterion": "prior treatment with antibodies against immune co-stimulators",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "any other therapy targeting a tumor's immune mechanism of action",
"criterion": "prior treatment with any other therapy targeting a tumor's immune mechanism of action",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior treatment with immune checkpoint inhibitors",
"criterion": "prior treatment with immune checkpoint inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other anti-PD-1, anti-PD-L1 antibodies",
"criterion": "prior treatment with anti-PD-1 or anti-PD-L1 antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "CTLA-4 antibodies",
"criterion": "prior treatment with CTLA-4 antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.)",
"criterion": "prior treatment with antibodies against immune co-stimulators",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "any other therapy targeting a tumor's immune mechanism of action",
"criterion": "prior treatment with any other therapy targeting a tumor's immune mechanism of action",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;",
"criterions": [
{
"exact_snippets": "Known hypersensitivity to any component",
"criterion": "hypersensitivity to trial medication component",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to ... any excipient of the trial prescribed medication",
"criterion": "hypersensitivity to trial medication excipient",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Known hypersensitivity to any component",
"criterion": "hypersensitivity to trial medication component",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypersensitivity to ... any excipient of the trial prescribed medication",
"criterion": "hypersensitivity to trial medication excipient",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;",
"criterions": [
{
"exact_snippets": "Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing",
"criterion": "immunosuppressive drugs or systemic corticosteroids",
"requirement": {
"requirement_type": "use",
"expected_value": false
}
},
{
"exact_snippets": "Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing",
"criterion": "immunosuppressive drugs or systemic corticosteroids",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 2 weeks prior to trial dosing"
}
},
{
"exact_snippets": "topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted",
"criterion": "topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids",
"requirement": {
"requirement_type": "use",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing",
"criterion": "immunosuppressive drugs or systemic corticosteroids",
"requirement": {
"requirement_type": "use",
"expected_value": false
}
},
{
"exact_snippets": "Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing",
"criterion": "immunosuppressive drugs or systemic corticosteroids",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 2 weeks prior to trial dosing"
}
}
]
},
{
"not_criteria": {
"exact_snippets": "topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted",
"criterion": "topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids",
"requirement": {
"requirement_type": "use",
"expected_value": true
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;",
"criterions": [
{
"exact_snippets": "Received herbs with antitumor effects",
"criterion": "herbs with antitumor effects",
"requirement": {
"requirement_type": "received",
"expected_value": true
}
},
{
"exact_snippets": "Received herbs with antitumor effects",
"criterion": "herbs with antitumor effects",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks prior to the trial"
}
}
},
{
"exact_snippets": "drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2)",
"criterion": "drugs with immunomodulatory effects",
"requirement": {
"requirement_type": "received",
"expected_value": true
}
},
{
"exact_snippets": "drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2)",
"criterion": "drugs with immunomodulatory effects",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks prior to the trial"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Received herbs with antitumor effects",
"criterion": "herbs with antitumor effects",
"requirement": {
"requirement_type": "received",
"expected_value": true
}
},
{
"exact_snippets": "Received herbs with antitumor effects",
"criterion": "herbs with antitumor effects",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks prior to the trial"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2)",
"criterion": "drugs with immunomodulatory effects",
"requirement": {
"requirement_type": "received",
"expected_value": true
}
},
{
"exact_snippets": "drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2)",
"criterion": "drugs with immunomodulatory effects",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks prior to the trial"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "6. Active systemic infection requiring systemic treatment;",
"criterions": [
{
"exact_snippets": "Active systemic infection requiring systemic treatment",
"criterion": "systemic infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "Active systemic infection requiring systemic treatment",
"criterion": "systemic infection",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "systemic treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Active systemic infection requiring systemic treatment",
"criterion": "systemic infection",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "Active systemic infection requiring systemic treatment",
"criterion": "systemic infection",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "systemic treatment"
}
}
]
}
},
{
"identified_line": {
"line": "7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;",
"criterions": [
{
"exact_snippets": "Serious infection within 4 weeks prior to the first dose",
"criterion": "serious infection",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to the first dose"
}
},
{
"exact_snippets": "complications requiring hospitalization",
"criterion": "complications requiring hospitalization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sepsis",
"criterion": "sepsis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe pneumonia",
"criterion": "severe pneumonia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Serious infection within 4 weeks prior to the first dose",
"criterion": "serious infection",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to the first dose"
}
},
{
"or_criteria": [
{
"exact_snippets": "complications requiring hospitalization",
"criterion": "complications requiring hospitalization",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sepsis",
"criterion": "sepsis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe pneumonia",
"criterion": "severe pneumonia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL), and patients with cured hepatitis C are eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;",
"criterions": [
{
"exact_snippets": "untreated chronic hepatitis B",
"criterion": "chronic hepatitis B",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL",
"criterion": "HBV DNA level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1000,
"unit": "IU/mL"
}
}
},
{
"exact_snippets": "active hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "Inactive HBsAg carriers",
"criterion": "HBsAg carrier status",
"requirement": {
"requirement_type": "activity",
"expected_value": "inactive"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "received treatment"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "condition",
"expected_value": "stable"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "HBV DNA level",
"expected_value": {
"operator": "<",
"value": 1000,
"unit": "IU/mL"
}
}
},
{
"exact_snippets": "patients with cured hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "status",
"expected_value": "cured"
}
},
{
"exact_snippets": "HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test",
"criterion": "HCV antibody status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test",
"criterion": "HCV antibody status",
"requirement": {
"requirement_type": "HCV RNA test",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "untreated chronic hepatitis B",
"criterion": "chronic hepatitis B",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Inactive HBsAg carriers",
"criterion": "HBsAg carrier status",
"requirement": {
"requirement_type": "activity",
"expected_value": "inactive"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "received treatment"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "condition",
"expected_value": "stable"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "HBV DNA level",
"expected_value": {
"operator": "<",
"value": 1000,
"unit": "IU/mL"
}
}
}
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL",
"criterion": "HBV DNA level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1000,
"unit": "IU/mL"
}
}
},
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Inactive HBsAg carriers",
"criterion": "HBsAg carrier status",
"requirement": {
"requirement_type": "activity",
"expected_value": "inactive"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "received treatment"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "condition",
"expected_value": "stable"
}
},
{
"exact_snippets": "patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL)",
"criterion": "hepatitis B treatment status",
"requirement": {
"requirement_type": "HBV DNA level",
"expected_value": {
"operator": "<",
"value": 1000,
"unit": "IU/mL"
}
}
}
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "active hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"not_criteria": {
"exact_snippets": "patients with cured hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "status",
"expected_value": "cured"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test",
"criterion": "HCV antibody status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test",
"criterion": "HCV antibody status",
"requirement": {
"requirement_type": "HCV RNA test",
"expected_value": "negative"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;",
"criterions": [
{
"exact_snippets": "Known active tuberculosis (TB)",
"criterion": "active tuberculosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "patients with suspected active TB should undergo chest X-ray",
"criterion": "chest X-ray for suspected active TB",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "patients with suspected active TB should undergo ... sputum examination",
"criterion": "sputum examination for suspected active TB",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "patients with suspected active TB should undergo ... clinical signs and symptoms",
"criterion": "clinical signs and symptoms for suspected active TB",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Known active tuberculosis (TB)",
"criterion": "active tuberculosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "patients with suspected active TB should undergo chest X-ray",
"criterion": "chest X-ray for suspected active TB",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "patients with suspected active TB should undergo ... sputum examination",
"criterion": "sputum examination for suspected active TB",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "patients with suspected active TB should undergo ... clinical signs and symptoms",
"criterion": "clinical signs and symptoms for suspected active TB",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);",
"criterions": [
{
"exact_snippets": "Immunodeficiency",
"criterion": "immunodeficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "human immunodeficiency virus (HIV antibody positive)",
"criterion": "HIV antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Immunodeficiency",
"criterion": "immunodeficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "human immunodeficiency virus (HIV antibody positive)",
"criterion": "HIV antibody",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;",
"criterions": [
{
"exact_snippets": "active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)",
"criterion": "history of inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "unable to swallow",
"criterion": "ability to swallow",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "malabsorption syndrome",
"criterion": "malabsorption syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uncontrolled nausea",
"criterion": "nausea",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "uncontrolled ... vomiting",
"criterion": "vomiting",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "uncontrolled ... diarrhea",
"criterion": "diarrhea",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "other gastrointestinal disorders that severely interfere with drug intake and absorption",
"criterion": "gastrointestinal disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "severely interfere with drug intake and absorption"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)",
"criterion": "history of inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "unable to swallow",
"criterion": "ability to swallow",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "malabsorption syndrome",
"criterion": "malabsorption syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "uncontrolled nausea",
"criterion": "nausea",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "uncontrolled ... vomiting",
"criterion": "vomiting",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "uncontrolled ... diarrhea",
"criterion": "diarrhea",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "other gastrointestinal disorders that severely interfere with drug intake and absorption",
"criterion": "gastrointestinal disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "severely interfere with drug intake and absorption"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;",
"criterions": [
{
"exact_snippets": "Known interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "interstitial lung disease that is symptomatic",
"criterion": "interstitial lung disease symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "interstitial lung disease ... may interfere with detection or treatment of immune-associated pneumonia",
"criterion": "interference with detection or treatment of immune-associated pneumonia",
"requirement": {
"requirement_type": "potential interference",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Known interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "interstitial lung disease that is symptomatic",
"criterion": "interstitial lung disease symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "interstitial lung disease ... may interfere with detection or treatment of immune-associated pneumonia",
"criterion": "interference with detection or treatment of immune-associated pneumonia",
"requirement": {
"requirement_type": "potential interference",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;",
"criterions": [
{
"exact_snippets": "Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose",
"criterion": "live or attenuated vaccine",
"requirement": {
"requirement_type": "treatment timing",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "inactivated seasonal influenza virus vaccine is permitted",
"criterion": "inactivated seasonal influenza virus vaccine",
"requirement": {
"requirement_type": "permission",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose",
"criterion": "live or attenuated vaccine",
"requirement": {
"requirement_type": "treatment timing",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"exact_snippets": "inactivated seasonal influenza virus vaccine is permitted",
"criterion": "inactivated seasonal influenza virus vaccine",
"requirement": {
"requirement_type": "permission",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "14. Have received a prior allogeneic bone marrow transplant or solid organ transplant;",
"criterions": [
{
"exact_snippets": "received a prior allogeneic bone marrow transplant",
"criterion": "prior allogeneic bone marrow transplant",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received a prior ... solid organ transplant",
"criterion": "prior solid organ transplant",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "received a prior allogeneic bone marrow transplant",
"criterion": "prior allogeneic bone marrow transplant",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received a prior ... solid organ transplant",
"criterion": "prior solid organ transplant",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "15. History of primary malignant tumor within the last 5 years;",
"criterions": [
{
"exact_snippets": "History of primary malignant tumor within the last 5 years",
"criterion": "primary malignant tumor",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of primary malignant tumor within the last 5 years",
"criterion": "primary malignant tumor",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "History of primary malignant tumor within the last 5 years",
"criterion": "primary malignant tumor",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of primary malignant tumor within the last 5 years",
"criterion": "primary malignant tumor",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "16. Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;",
"criterions": [
{
"exact_snippets": "Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.)",
"criterion": "major surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe trauma within 28 days prior to the first dose",
"criterion": "severe trauma",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.)",
"criterion": "major surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe trauma within 28 days prior to the first dose",
"criterion": "severe trauma",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "17. With a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;",
"criterions": [
{
"exact_snippets": "history of gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... gastrointestinal fistula",
"criterion": "gastrointestinal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... female genital fistula",
"criterion": "female genital fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "history of gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... gastrointestinal fistula",
"criterion": "gastrointestinal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "history of ... female genital fistula",
"criterion": "female genital fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance/requiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;",
"criterions": [
{
"exact_snippets": "Uncontrolled other co-morbidities, symptoms, or medical history",
"criterion": "uncontrolled co-morbidities, symptoms, or medical history",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance/requiring pharmacologic intervention",
"criterion": "cardiovascular diseases or cardiovascular risk factors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above)",
"criterion": "congestive heart failure symptoms",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above)",
"criterion": "congestive heart failure symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": "New York Heart Association (NYHA) class III and above"
}
},
{
"exact_snippets": "clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose",
"criterion": "significant bleeding symptoms or history",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
},
{
"exact_snippets": "clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction",
"criterion": "clinically active hemoptysis, diverticulitis, abdominal abscesses, and gastrointestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites",
"criterion": "uncontrolled pleural effusion, pericardial effusion, or ascites",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "Repeated drainage of ascites"
}
},
{
"exact_snippets": "Abnormal liver or kidney development or history of surgery",
"criterion": "abnormal liver or kidney development or history of surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrolled other co-morbidities, symptoms, or medical history",
"criterion": "uncontrolled co-morbidities, symptoms, or medical history",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"or_criteria": [
{
"exact_snippets": "persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance/requiring pharmacologic intervention",
"criterion": "cardiovascular diseases or cardiovascular risk factors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"and_criteria": [
{
"exact_snippets": "persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above)",
"criterion": "congestive heart failure symptoms",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above)",
"criterion": "congestive heart failure symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": "New York Heart Association (NYHA) class III and above"
}
}
]
}
]
}
]
},
{
"exact_snippets": "clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose",
"criterion": "significant bleeding symptoms or history",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
},
{
"exact_snippets": "clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction",
"criterion": "clinically active hemoptysis, diverticulitis, abdominal abscesses, and gastrointestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites",
"criterion": "uncontrolled pleural effusion, pericardial effusion, or ascites",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": "Repeated drainage of ascites"
}
},
{
"exact_snippets": "Abnormal liver or kidney development or history of surgery",
"criterion": "abnormal liver or kidney development or history of surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding female patients",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "women of childbearing age",
"criterion": "women of childbearing age",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "refuse to accept contraceptive measures during neoadjuvant immunotherapy",
"criterion": "acceptance of contraceptive measures",
"requirement": {
"requirement_type": "acceptance",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding female patients",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "women of childbearing age",
"criterion": "women of childbearing age",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "refuse to accept contraceptive measures during neoadjuvant immunotherapy",
"criterion": "acceptance of contraceptive measures",
"requirement": {
"requirement_type": "acceptance",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "20. Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;",
"criterions": [
{
"exact_snippets": "Concurrent participation in other interventional clinical trials",
"criterion": "concurrent participation in interventional clinical trials",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "participation in observational and non-interventional clinical trials is permitted",
"criterion": "participation in observational and non-interventional clinical trials",
"requirement": {
"requirement_type": "permission",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Concurrent participation in other interventional clinical trials",
"criterion": "concurrent participation in interventional clinical trials",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "participation in observational and non-interventional clinical trials is permitted",
"criterion": "participation in observational and non-interventional clinical trials",
"requirement": {
"requirement_type": "permission",
"expected_value": true
}
}
]
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "1. FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size≥4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);",
"criterions": [
{
"exact_snippets": "FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r ... cervical cancer",
"criterion": "cervical cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IB3",
"IIA2",
"IIB",
"IIIC1r"
]
}
},
{
"exact_snippets": "tumor size≥4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "cm"
}
}
},
{
"exact_snippets": "without any treatment",
"criterion": "treatment status",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r ... cervical cancer",
"criterion": "cervical cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IB3"
]
}
},
{
"exact_snippets": "tumor size≥4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "cm"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r ... cervical cancer",
"criterion": "cervical cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IIA2"
]
}
},
{
"exact_snippets": "tumor size≥4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "cm"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r ... cervical cancer",
"criterion": "cervical cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IIB"
]
}
},
{
"exact_snippets": "tumor size≥4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "cm"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r ... cervical cancer",
"criterion": "cervical cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"IIIC1r"
]
}
},
{
"exact_snippets": "tumor size≥4cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "cm"
}
}
}
]
}
]
},
{
"exact_snippets": "without any treatment",
"criterion": "treatment status",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "21. Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results. Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements are not permitted to participate in this study.",
"criterions": [
{
"exact_snippets": "Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug",
"criterion": "condition causing risk with study drug",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "condition that ... would interfere with the evaluation of the safety of the study drug",
"criterion": "condition interfering with safety evaluation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "condition that ... would interfere with ... the interpretation of the study results",
"criterion": "condition interfering with study results interpretation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements",
"criterion": "compliance with study protocol",
"requirement": {
"requirement_type": "likelihood",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug",
"criterion": "condition causing risk with study drug",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "condition that ... would interfere with the evaluation of the safety of the study drug",
"criterion": "condition interfering with safety evaluation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "condition that ... would interfere with ... the interpretation of the study results",
"criterion": "condition interfering with study results interpretation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements",
"criterion": "compliance with study protocol",
"requirement": {
"requirement_type": "likelihood",
"expected_value": false
}
}
]
}
}
],
"failed_miscellaneous": []
}