Clinical Trial

A Study to Evaluate the Association of Biliary Complications and Treatment Duration in Unresectable BTC Patients

Study acronym: ARCBile
Completed
View on ClinicalTrials.gov →
Summary
This is a multi-center, retrospective, observational study of patients receiving first-line systemic therapy as routine clinical care for unresectable BTC in Japan. This study attempts to test the hypothesis that the occurrence of biliary complications requiring hospitalization during first-line systemic therapy for unresectable BTC, which is as a time-dependent covariate, affects time to treatment failure (TTF) .
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-07-30; most recent amendment 2026-04-16.
Status change: Recruiting → Completed 2026-03-26
Status change: Not Yet Recruiting → Recruiting 2025-09-03
Trial Details
NCT Number NCT07101874
Lead Sponsor AstraZeneca
Collaborators: Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP)
Conditions Biliary Tract Cancer
Enrollment 729 participants
Start Date 2025-08-22
Primary Completion 2026-02-28 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-04-17