NCT07101874

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

A Retrospective Study of Biliary Complications and Treatment Duration in Patients With Biliary Tract Cancer Receiving Systemic Therapy in Japan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 729 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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) .

Detailed description

The real-world evidence on cancer-related biliary complications during systemic therapy in patients with advanced biliary tract cancers (BTC) in a large population is lacking. The results from this study may reveal the association of biliary complications with treatment duration, provide an overview of the current status of managing them, and clarify the issues to be addressed as a priority in future studies. This is a multi-center, retrospective, observational study of patients receiving first-line systemic therapy as routine clinical care for unresectable BTC in Japan. The primary objective of this study is to evaluate the association of the occurrence of biliary complication during first-line systemic therapy with time to treatment failure (TTF) in unresectable BTC patients, to test the hypothesis that the occurrence of biliary complications requiring hospitalization during first-line systemic therapy for unresectable BTC as a time-dependent covariate is significantly associated with TTF . This study is conducted in collaboration with Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP, https://jon-hbp.org/en/). Approximately 1,000 patients who start the first dose of first-line systemic therapy for unresectable BTC between May 1, 2022, and December 31, 2023, will be enrolled and these patients' data until July 31, 2025 in medical charts will be collected.

Conditions

• Biliary Tract Cancer

Timeline

• Start date: 2025-08-22
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-08-03
• Last updated: 2026-04-17

Locations

22 sites across 1 country: Japan