Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT06718257
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '1 year', 'description': 'Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 year', 'description': 'Progression-free survival (PFS) is defined as the time from the start of treatment until disease progression or the emergence of new lesions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced cholangiocarcinoma', 'chemotherapy combined with immunotherapy and targeted therapy', 'clinical efficacy and safety'], 'conditions': ['Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.', 'detailedDescription': 'This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were histologically or radiologically confirmed intrahepatic cholangiocarcinoma, with initial treatment consisting of GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or radiologically confirmed intrahepatic cholangiocarcinoma\n* Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors\n\nExclusion Criteria:\n\n* Direct surgery after hospitalization\n* Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)\n* Initial treatment involving other comprehensive therapeutic regimens'}, 'identificationModule': {'nctId': 'NCT06718257', 'briefTitle': 'Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma', 'orgStudyIdInfo': {'id': '2024-1058'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Patients initially received GP/GEMOX regimen.', 'interventionNames': ['Drug: Gemcitabine combined with cisplatin or oxaliplatin']}, {'label': 'Experimental group', 'description': 'Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen.', 'interventionNames': ['Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors']}], 'interventions': [{'name': 'Gemcitabine combined with cisplatin or oxaliplatin', 'type': 'DRUG', 'description': 'Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)', 'armGroupLabels': ['Control group']}, {'name': 'Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors', 'type': 'DRUG', 'description': 'Gemcitabine (1000 mg/m², day 1 and 8), cisplatin (75 mg/m²; day 1) or oxaliplatin (85 mg/m²; day 1), PD-1/L1 agents (200 mg; day 1), and TKI inhibitors (8 mg; per day)', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weilin Wang, PHD', 'role': 'CONTACT', 'email': 'wam@zju.edu.cn', 'phone': '+86 057187783820'}, {'name': 'Yuan Ding, PHD', 'role': 'CONTACT', 'email': 'dingyuan@zju.edu', 'phone': '+86 18858101960'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Weilin Wang, PHD', 'role': 'CONTACT', 'email': 'wam@zju.edu.cn', 'phone': '+86 057187783820'}, {'name': 'Yuan Ding, PHD', 'role': 'CONTACT', 'email': 'dingyuan@zju.edu', 'phone': '+86 18858101960'}], 'overallOfficials': [{'name': 'Weilin Wang, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}