Biliary Tract CancerARCBileNCT07101874

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

An observational study of Biliary Tract Cancer, run by AstraZeneca at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Biliary Tract Cancer
How many people: 729 participants
Where: 22 sitesJapan
Study dates: 22 Aug 2025to 28 Feb 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

1. 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.
2. 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.
3. 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.
5. Patients aged 18 years or older at the date of first dose of first-line systemic therapy for unresectable BTC.
6. Patients who started first-line systemic therapy with physician's expectation of 3 months or longer prognosis at the time of starting systemic therapy.

Who cannot join

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).

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Japan22 sites

Research Site
Aichi
Research Site
Chiba
Research Site
Ehime
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ishikawa
Research Site
Kagawa
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kyoto
Research Site
Miyagi
Research Site
Nara
Research Site
Ōita
Research Site
Okayama
Research Site
Osaka
Research Site
Saitama
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokyo
Research Site
Wakayama

Other trials in Japan

About this study

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

Read the 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
Medical subject headings: Biliary Tract Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
All information related the first biliary complication.
Measured: The duration of hospitalization due to the first biliary complication requiring admission up to July 31, 2025.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202528 Feb 2026

First posted3 Aug 2025
Study start22 Aug 2025
Primary completion28 Feb 2026
Study completion28 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 729 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07101874
Sponsor's protocol ID: D4191R00099
Acronym: ARCBile
Status last verified: Apr 2026
First submitted: 10 Jun 2025
Last updated: 17 Apr 2026
Results posted: No
Individual data sharing: Yes: Qualified researchers can request access to de-identified individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma

All Biliary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Study of Biliary Complications and Treatment Duration in Patients With Biliary Tract Cancer Receiving Systemic Therapy in Japan
ClinicalTrials.gov ID: NCT07101874
Acronym / sponsor ID: ARCBile / D4191R00099
Conditions: Biliary Tract Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 729 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP)
Study start: 22 Aug 2025 (actual)
Primary completion: 28 Feb 2026 (actual)
Study completion: 28 Feb 2026 (actual)
First posted: 3 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a multi-center, retrospective, observational study of patients receiving first-line systemic therapy as routine clinical care for unresectable BTC in Japan.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (7 listed)

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.
2. 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.
3. 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.
5. Patients aged 18 years or older at the date of first dose of first-line systemic therapy for unresectable BTC.

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Time to treatment failure (TTF)
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.
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.

3 secondary outcomes

The number and proportion of patients with each reason for discontinuation (including disease progression and cause of death) of first-line systemic therapy.
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.
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 detail following information of the first biliary complication during first-line systemic therapy, e.g., Disease classification, Bacteremia, Main site of obstruction or stenosis.
Time frame: The duration of hospitalization due to the first biliary complication requiring admission up to July 31, 2025.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to de-identified individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Related trials for Biliary Tract Cancer

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Tract Cancer, run by AstraZeneca at 22 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to treatment failure (TTF) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07101874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.