CompletedNot Applicable

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

Japan729 participantsStarted 2025-08-22

Plain-language 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) .

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients who were deemed unamenable to curative resection at the initial diagnosis.
✓. Patients who relapsed after curative resection of BTC more than 6 months after the end of adjuvant therapy or after the date of surgery for patients who did not receive adjuvant therapy.

Exclusion criteria

✕. Maintenance dialysis at the date of the first dose of first-line systemic therapy for unresectable BTC.
✕. Combined any locoregional therapy with first-line systemic therapy for unresectable BTC (e.g., radiation therapy, radiofrequency ablation, arterial injection chemotherapy)
✕. Patient who participated in clinical trials (interventional studies) of first-line systemic therapy for BTC
✕. Active cancers other than unresectable BTC within the past 2 years from the date of the first dose of first-line systemic therapy. The following are exceptions to this criterion:
✕. Patients who were followed up for less than 3 months after starting first-line systemic therapy for reasons other than TTF events (disease progression, death, or treatment discontinuation).

What they're measuring

Time to treatment failure (TTF)

Timeframe: From 1st dose of first-line systemic therapy until disease progression or death by any cause or discontinuation of first-line systemic therapy for unresectable BTC by physician's decision, whichever came first, assessed up to 2 years.

Trial details

NCT IDNCT07101874

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Biliary Tract Cancer trials