[96a5a0]: / output / allTrials / identified / NCT06128460_identified.json

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{
"info": {
"nct_id": "NCT06128460",
"official_title": "Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients",
"inclusion_criteria": "* Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;\n* According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;\n* Patients with radical surgery for cervical cancer;\n* Female patients: 18-70 years old;\n* ECOG physical condition score: 0~1 point;\n* Subjects have not received previous immunotherapy;\n* Expected survival ≥6 months;\n* Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;\n* For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy\n* Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Subjects have histological subtypes other than those permitted by inclusion criteria;\n* Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);\n* Participate in or have participated in other clinical trials within 4 weeks before enrollment;\n* Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;\n* Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;\n* Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;\n* Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);\n* Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;\n* An active infection requiring systematic treatment;\n* Known history of HIV infection;\n* A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA[qualitative]) infection;\n* Known active tuberculosis (TB; Tuberculosis) medical history;\n* Has received allogeneic tissue/solid organ transplantation;\n* Suffering from central nervous system metastases such as brain metastases;\n* Patients with uncontrolled chest and abdominal fluid;\n* Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;\n* Insufficient hematopoietic function of bone marrow;\n* Abnormal liver;\n* Abnormal kidney;\n* Bleeding risk;\n* Cardiovascular and cerebrovascular abnormalities.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;",
"criterions": [
{
"exact_snippets": "Histologically confirmed cervical squamous cell carcinoma",
"criterion": "cervical squamous cell carcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "Histologically confirmed ... cervical adenocarcinoma",
"criterion": "cervical adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "Histologically confirmed ... cervical adenosquamous carcinoma",
"criterion": "cervical adenosquamous carcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;",
"criterions": [
{
"exact_snippets": "FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2)",
"criterion": "cervical cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"IB3",
"IIA2"
]
}
]
},
{
"exact_snippets": "require concurrent radiotherapy and chemotherapy",
"criterion": "treatment requirement",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": [
"concurrent radiotherapy",
"chemotherapy"
]
}
]
}
]
},
{
"line": "* Patients with radical surgery for cervical cancer;",
"criterions": [
{
"exact_snippets": "radical surgery for cervical cancer",
"criterion": "radical surgery",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "cervical cancer"
}
]
}
]
},
{
"line": "* Female patients: 18-70 years old;",
"criterions": [
{
"exact_snippets": "Female patients",
"criterion": "gender",
"requirements": [
{
"requirement_type": "value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "18-70 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* ECOG physical condition score: 0~1 point;",
"criterions": [
{
"exact_snippets": "ECOG physical condition score: 0~1 point;",
"criterion": "ECOG physical condition score",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "point"
},
{
"operator": "<=",
"value": 1,
"unit": "point"
}
]
}
}
]
}
]
},
{
"line": "* Subjects have not received previous immunotherapy;",
"criterions": [
{
"exact_snippets": "Subjects have not received previous immunotherapy",
"criterion": "previous immunotherapy",
"requirements": [
{
"requirement_type": "receipt",
"expected_value": false
}
]
}
]
},
{
"line": "* Expected survival ≥6 months;",
"criterions": [
{
"exact_snippets": "Expected survival ≥6 months",
"criterion": "expected survival",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;",
"criterions": [
{
"exact_snippets": "Women of reproductive age",
"criterion": "gender and reproductive age",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends",
"criterion": "contraceptive use",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "during the study period and for 6 months after the study ends"
}
]
},
{
"exact_snippets": "Have a negative serum or urine pregnancy test within 7 days prior to study enrollment",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
},
{
"requirement_type": "timing",
"expected_value": "within 7 days prior to study enrollment"
}
]
},
{
"exact_snippets": "must be a non-lactating patient",
"criterion": "lactation status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "non-lactating"
}
]
}
]
},
{
"line": "* For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy",
"criterions": [
{
"exact_snippets": "adequate organ function",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "test samples must be collected within 7 days prior to initiation of the study therapy",
"criterion": "test sample collection timing",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.",
"criterions": [
{
"exact_snippets": "Subjects voluntarily joined the study",
"criterion": "voluntary participation",
"requirements": [
{
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
},
{
"exact_snippets": "had good compliance",
"criterion": "compliance",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "good"
}
]
},
{
"exact_snippets": "cooperated with follow-up",
"criterion": "follow-up cooperation",
"requirements": [
{
"requirement_type": "cooperation",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Subjects have histological subtypes other than those permitted by inclusion criteria;",
"criterions": [
{
"exact_snippets": "Subjects have histological subtypes other than those permitted by inclusion criteria",
"criterion": "histological subtypes",
"requirements": [
{
"requirement_type": "permitted",
"expected_value": false
}
]
}
]
},
{
"line": "* Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3);",
"criterions": [
{
"exact_snippets": "Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3)",
"criterion": "hypersensitivity to cepalizumab",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "grade"
}
}
]
},
{
"exact_snippets": "Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3)",
"criterion": "hypersensitivity to any excipients of cepalizumab",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "grade"
}
}
]
}
]
},
{
"line": "* Participate in or have participated in other clinical trials within 4 weeks before enrollment;",
"criterions": [
{
"exact_snippets": "Participate in or have participated in other clinical trials within 4 weeks before enrollment",
"criterion": "participation in other clinical trials",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 4,
"unit": "weeks"
}
]
}
}
]
}
]
},
{
"line": "* Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;",
"criterions": [
{
"exact_snippets": "Have received or will receive inactivated vaccine within 30 days prior to the first study treatment",
"criterion": "inactivated vaccine",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "within 30 days prior to the first study treatment"
}
]
}
]
},
{
"line": "* Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;",
"criterions": [
{
"exact_snippets": "Received a combination of systemic immune stimulants",
"criterion": "systemic immune stimulants",
"requirements": [
{
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "Received a combination of ... colony-stimulating factors",
"criterion": "colony-stimulating factors",
"requirements": [
{
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "Received a combination of ... interferon",
"criterion": "interferon",
"requirements": [
{
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "Received a combination of ... interleukin",
"criterion": "interleukin",
"requirements": [
{
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "Received a combination of ... vaccine",
"criterion": "vaccine",
"requirements": [
{
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "weeks"
}
]
}
}
]
}
]
},
{
"line": "* Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;",
"criterions": [
{
"exact_snippets": "Have been diagnosed with an immune deficiency",
"criterion": "immune deficiency",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone)",
"criterion": "chronic systemic steroid therapy",
"requirements": [
{
"requirement_type": "dose",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "mg daily equivalent of prednisone"
}
}
]
},
{
"exact_snippets": "receiving ... any other form of immunosuppressive therapy within 7 days prior to the first dose",
"criterion": "immunosuppressive therapy",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within 7 days prior to the first dose"
}
]
}
]
},
{
"line": "* Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);",
"criterions": [
{
"exact_snippets": "active autoimmune disease",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "activity",
"expected_value": true
}
]
},
{
"exact_snippets": "in the past 2 years",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "past 2 years"
}
]
},
{
"exact_snippets": "requires systemic treatment",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "treatment requirement",
"expected_value": true
}
]
},
{
"exact_snippets": "disease-modulating drugs, corticosteroids, or immunosuppressive drugs",
"criterion": "systemic treatment",
"requirements": [
{
"requirement_type": "types",
"expected_value": [
"disease-modulating drugs",
"corticosteroids",
"immunosuppressive drugs"
]
}
]
}
]
},
{
"line": "* Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;",
"criterions": [
{
"exact_snippets": "Have a history of (non-infectious) pneumonia requiring steroid treatment",
"criterion": "history of non-infectious pneumonia",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": "steroid treatment"
}
]
},
{
"exact_snippets": "have a current (non-infectious) pneumonia",
"criterion": "current non-infectious pneumonia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* An active infection requiring systematic treatment;",
"criterions": [
{
"exact_snippets": "An active infection requiring systematic treatment",
"criterion": "active infection",
"requirements": [
{
"requirement_type": "treatment necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Known history of HIV infection;",
"criterions": [
{
"exact_snippets": "Known history of HIV infection",
"criterion": "HIV infection",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA[qualitative]) infection;",
"criterions": [
{
"exact_snippets": "A known history of hepatitis B (defined as HBsAg reactive)",
"criterion": "hepatitis B",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "HBsAg reactivity",
"expected_value": true
}
]
},
{
"exact_snippets": "known active hepatitis C virus (defined as detection of HCV RNA[qualitative]) infection",
"criterion": "hepatitis C virus",
"requirements": [
{
"requirement_type": "activity",
"expected_value": true
},
{
"requirement_type": "HCV RNA detection",
"expected_value": true
}
]
}
]
},
{
"line": "* Known active tuberculosis (TB; Tuberculosis) medical history;",
"criterions": [
{
"exact_snippets": "Known active tuberculosis (TB; Tuberculosis) medical history",
"criterion": "tuberculosis",
"requirements": [
{
"requirement_type": "status",
"expected_value": "active"
},
{
"requirement_type": "medical history",
"expected_value": true
}
]
}
]
},
{
"line": "* Has received allogeneic tissue/solid organ transplantation;",
"criterions": [
{
"exact_snippets": "Has received allogeneic tissue/solid organ transplantation",
"criterion": "allogeneic tissue/solid organ transplantation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Suffering from central nervous system metastases such as brain metastases;",
"criterions": [
{
"exact_snippets": "central nervous system metastases",
"criterion": "central nervous system metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients with uncontrolled chest and abdominal fluid;",
"criterions": [
{
"exact_snippets": "uncontrolled chest and abdominal fluid",
"criterion": "chest fluid",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
},
{
"exact_snippets": "uncontrolled chest and abdominal fluid",
"criterion": "abdominal fluid",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;",
"criterions": [
{
"exact_snippets": "mobility disorders",
"criterion": "mobility disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pathological fractures",
"criterion": "pathological fractures",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "tumor bone metastasis",
"criterion": "tumor bone metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Insufficient hematopoietic function of bone marrow;",
"criterions": [
{
"exact_snippets": "Insufficient hematopoietic function of bone marrow",
"criterion": "hematopoietic function of bone marrow",
"requirements": [
{
"requirement_type": "sufficiency",
"expected_value": false
}
]
}
]
},
{
"line": "* Abnormal liver;",
"criterions": [
{
"exact_snippets": "Abnormal liver",
"criterion": "liver",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "abnormal"
}
]
}
]
},
{
"line": "* Abnormal kidney;",
"criterions": [
{
"exact_snippets": "Abnormal kidney",
"criterion": "kidney",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "abnormal"
}
]
}
]
},
{
"line": "* Bleeding risk;",
"criterions": [
{
"exact_snippets": "Bleeding risk",
"criterion": "bleeding risk",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Cardiovascular and cerebrovascular abnormalities.",
"criterions": [
{
"exact_snippets": "Cardiovascular ... abnormalities",
"criterion": "cardiovascular abnormalities",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "cerebrovascular abnormalities",
"criterion": "cerebrovascular abnormalities",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}