Clinical Trial

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

Study acronym: ACTICCA-1
Active, Not Recruiting Phase 3
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Record status
This record was last updated March 30, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2014-06-20; most recent amendment 2025-03-25.
Status change: Recruiting → Active, Not Recruiting 2023-01-22
Trial Details
NCT Number NCT02170090
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany), Cancer Research UK, Australasian Gastro-Intestinal Trials Group, Dutch Cancer Society
Conditions Cholangiocarcinoma, Gall Bladder Carcinoma
Enrollment 789 participants
Start Date 2014-04
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-30