A Study to Evaluate the Association of Biliary Complications and Treatment Duration in Unresectab… (NCT07101874) | Clinical Trial Compass
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
Sex
ALL
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study focused on biliary complications in people with unresectable biliary tract cancer — can you explain what biliary complications are and how they might affect my own treatment plan or how long I could stay on treatment?
2Since this trial measured 'time to treatment failure,' what does that outcome actually mean in practice, and how does knowing that information help you decide which treatment approach might work best for me?
3The study is already completed but results may not yet be widely available — is there anything from this research that you're already aware of that could inform my care for unresectable biliary tract cancer?
4Because my biliary tract cancer is unresectable, what are the standard treatment options you would consider for me first, and how does evidence from observational studies like this one factor into those recommendations?
5Are there specific biliary complications I should watch out for during treatment, and based on what this study was examining, are there warning signs that would tell us my current treatment isn't working well enough??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. 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).