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Bile duct issues may shorten cancer treatment, study finds

NCT ID NCT07101874

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at medical records of 729 people in Japan with biliary tract cancer that could not be removed by surgery. Researchers wanted to see if bile duct problems during first treatment affected how long patients could stay on that treatment. The study did not test any new drug or procedure, but simply observed what happened in routine care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

729 people

The number who actually took part.

Started

Aug 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. Patients diagnosed with "unresectable BTC" who meet any of the following: 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. 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. Exclusion Criteria: 1. Maintenance dialysis at the date of the first dose of first-line systemic therapy for unresectable BTC. 2. Combined any locoregional therapy with first-line systemic therapy for unresectable BTC (e.g., radiation therapy, radiofrequency ablation, arterial injection chemotherapy) 3. Patient who participated in clinical trials (interventional studies) of first-line systemic therapy for BTC 4. 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. 5. 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).

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

Contacts and locations

Locations

  • Research Site

    Aichi, Japan

  • Research Site

    Chiba, Japan

  • Research Site

    Ehime, Japan

  • Research Site

    Fukuoka, Japan

  • Research Site

    Fukushima, Japan

  • Research Site

    Hokkaido, Japan

  • Research Site

    Hyōgo, Japan

  • Research Site

    Ishikawa, Japan

  • Research Site

    Kagawa, Japan

  • Research Site

    Kanagawa, Japan

  • Research Site

    Kochi, Japan

  • Research Site

    Kyoto, Japan

  • Research Site

    Miyagi, Japan

  • Research Site

    Nara, Japan

  • Research Site

    Okayama, Japan

  • Research Site

    Osaka, Japan

  • Research Site

    Ōita, Japan

  • Research Site

    Saitama, Japan

  • Research Site

    Shizuoka, Japan

  • Research Site

    Tochigi, Japan

  • Research Site

    Tokyo, Japan

  • Research Site

    Wakayama, Japan

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