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

NCT07101874 | Completed

• 1 other identifier: D4191R00099
• Study Type: observational
• Target: 729
• Locations: 1 country
• Sites: 22

Brief 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) .

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

  TTF is defined as the time from the first dose date of first-line systemic therapy to the earliest date of any following events; 1. Disease progression determined by physicians. 2. Death by any cause. 3. Discontinuation of first-line systemic therapy for unresectable BTC by physician's decision. The impact of biliary complications on first-line systemic therapy will be evaluated by HR with 95% confidence interval (CI) which is estimated with TTF and incidence rate of event in the patient group who developed biliary complication before a certain time t and patient group who did not develop biliary complication before time t.

  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.

Secondary Outcomes (3)

• The number and proportion of patients with each reason for discontinuation (including disease progression and cause of death) of first-line systemic therapy.

  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.

• The number and proportion of patients per the number (including zero) of occurrence of biliary complications during first-line systemic therapy.

  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.

• The detail following information of the first biliary complication during first-line systemic therapy, e.g., Disease classification, Bacteremia, Main site of obstruction or stenosis.

  The duration of hospitalization due to the first biliary complication requiring admission up to July 31, 2025.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of approximately 1,000 patients who received first-line systemic therapy for unresectable BTC including intrahepatic/perihilar/distal cholangiocarcinoma, GBC, or cancer of the AoV will be the study population. And in this study, the patients with unresectable BTC were defined as follows: 1. Patients who were deemed unamenable to curative resection at the initial diagnosis. 2. 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.

You may qualify if:

• \. Patients diagnosed with "unresectable BTC" who meet any of the following:
• 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.
• \. Patients who received first-line systemic therapy for unresectable BTC with the date of the first dose between May 1, 2022, and December 31, 2023. However, patients who received postoperative adjuvant therapy for BTC with R2 resection is not included.
• \. Patients with ECOG performance status 0 or 1 on the most recent assessment date prior to first dose of first-line systemic therapy for unresectable BTC 4. Patients who provided written informed consent form (ICF), in cases where obtaining informed consent is not difficult, or for whom an appropriate opt-out approach was taken at the study site if obtaining informed consent is difficult.
• \. Patients aged 18 years or older at the date of first dose of first-line systemic therapy for unresectable BTC.
• \. Patients who started first-line systemic therapy with physician's expectation of 3 months or longer prognosis at the time of starting systemic therapy.

You may not qualify if:

• 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:
• Carcinoma in situ or lesions equivalent to carcinoma in situ.
• Intramucosal cancers that are deemed cured by local treatment.
• 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).

Sponsors & Collaborators

• AstraZeneca: lead
• Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP): collaborator

Study Sites (22)

Research Site

Aichi, Japan

Location

Research Site

Chiba, Japan

Location

Research Site

Ehime, Japan

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Research Site

Fukuoka, Japan

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Research Site

Fukushima, Japan

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Research Site

Hokkaido, Japan

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Research Site

Hyōgo, Japan

Location

Research Site

Ishikawa, Japan

Location

Research Site

Kagawa, Japan

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Research Site

Kanagawa, Japan

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Research Site

Kochi, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Miyagi, Japan

Location

Research Site

Nara, Japan

Location

Research Site

Okayama, Japan

Location

Research Site

Osaka, Japan

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Research Site

Ōita, Japan

Location

Research Site

Saitama, Japan

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Research Site

Shizuoka, Japan

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Research Site

Tochigi, Japan

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Research Site

Tokyo, Japan

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Research Site

Wakayama, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: August 3, 2025
• Study Start: August 22, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

JP (22)