Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma
NCT ID: NCT06718257
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-09-01
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Control group
Patients initially received GP/GEMOX regimen.
Gemcitabine combined with cisplatin or oxaliplatin
Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)
Experimental group
Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen.
Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors
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)
Interventions
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Gemcitabine combined with cisplatin or oxaliplatin
Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)
Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors
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)
Eligibility Criteria
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Inclusion Criteria
* Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors
Exclusion Criteria
* Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
* Initial treatment involving other comprehensive therapeutic regimens
18 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Weilin Wang, PHD
Role: STUDY_CHAIR
Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-1058
Identifier Type: -
Identifier Source: org_study_id
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