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) .
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Research Site
Aichi, Japan
RECRUITINGResearch Site
Chiba, Japan
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.
Time frame: 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 with each reason for discontinuation (including disease progression and cause of death) of first-line systemic therapy.
Patient group: 1. Overall study population. 2. Patient group with/without pre-treatment biliary drainage before starting first-line systemic therapy within overall study population.
Time frame: 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.
Patient group: 1. Overall study population. 2. Patient group with/without pre-treatment biliary drainage before starting first-line systemic therapy within overall study population.
Time frame: 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.
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Research Site
Ehime, Japan
RECRUITINGResearch Site
Fukuoka, Japan
RECRUITINGResearch Site
Fukushima, Japan
RECRUITINGResearch Site
Hokkaido, Japan
RECRUITINGResearch Site
Hyōgo, Japan
RECRUITINGResearch Site
Ishikawa, Japan
RECRUITINGResearch Site
Kagawa, Japan
RECRUITINGResearch Site
Kanagawa, Japan
RECRUITING...and 12 more locations
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.
All information related the first biliary complication.
Time frame: The duration of hospitalization due to the first biliary complication requiring admission up to July 31, 2025.