Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 6:35 PM
Study NCT ID:
NCT06128460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719848', 'term': 'zimberelimab'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in tumor-related biomarkers', 'timeFrame': '3 years', 'description': 'changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '5 years', 'description': 'Overall Survival'}, {'measure': 'DFS', 'timeFrame': '2 years', 'description': 'Disease Free Survival'}, {'measure': 'AE', 'timeFrame': '3 years', 'description': 'Adverse event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.', 'detailedDescription': 'For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced/recurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT06128460', 'briefTitle': 'Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Obstetrics & Gynecology Hospital of Fudan University'}, 'officialTitle': 'Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients', 'orgStudyIdInfo': {'id': 'GLS-010-672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concurrent themoradiotherapy Followed by Zimberelimab', 'description': '1. Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f.\n2. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times;\n3. Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles', 'interventionNames': ['Drug: Zimberelimab', 'Drug: Platinum', 'Radiation: radiotherapy']}], 'interventions': [{'name': 'Zimberelimab', 'type': 'DRUG', 'description': '240mg, q3w，8 cycles', 'armGroupLabels': ['Concurrent themoradiotherapy Followed by Zimberelimab']}, {'name': 'Platinum', 'type': 'DRUG', 'description': 'cisplatin 40mg/m2 for 5-6 cycles', 'armGroupLabels': ['Concurrent themoradiotherapy Followed by Zimberelimab']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': '45-50Gy/1.8Gy/25-28f', 'armGroupLabels': ['Concurrent themoradiotherapy Followed by Zimberelimab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Junjun Qiu, Doctor', 'role': 'CONTACT', 'email': 'qiujunjun1113@163.com', 'phone': '18017738139'}], 'overallOfficials': [{'name': 'Keqin Hua, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecology and obstetrics hospital of fudan university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gynecological Oncology', 'investigatorFullName': 'Keqin Hua', 'investigatorAffiliation': 'Obstetrics & Gynecology Hospital of Fudan University'}}}}