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New combo therapy aims to stop bile duct cancer return after surgery

NCT ID NCT07636824

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing whether giving chemotherapy (capecitabine or S-1) together with radiation after surgery can help prevent bile duct and gallbladder cancers from coming back. It includes 92 patients whose cancers had high-risk features, like positive lymph nodes or narrow surgical margins. The main goal is to see how many patients remain cancer-free two years after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Capecitabine (or S-1) chemotherapy plus radiation therapy
What this could lead to
If successful, this could provide a standard treatment to reduce the chance of cancer returning after surgery for these aggressive cancers.
What could go wrong
This is a small, early-phase study (92 people) without a comparison group, so results may not be definitive. Chemoradiotherapy can cause significant side effects like fatigue, nausea, and low blood counts.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: * Aged 18-80 years * Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma * Postoperative pathology with ≥1 high-risk factor for recurrence 1. Narrow resection margin (\<1 cm), including R1 resection 2. Positive circumferential resection margin 3. T stage ≥ T3-4 4. Positive regional lymph nodes * Postoperative liver function: Child-Pugh grade A5-B7 * No recurrence or metastasis before postoperative radiotherapy * ECOG performance status 0-2 * Expected survival \>3 months * Routine blood tests: Neutrophils ≥1.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L * Liver function: Total bilirubin \<1.5×upper limit of normal (ULN), plus one of the following: 1. ALT and AST ≤2.5×ULN 2. ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction) * Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN * Voluntary participation and signed informed consent Exclusion Criteria: * History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ) * Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders) * Prior abdominal radiotherapy * Post-organ transplantation * Symptomatic moderate-severe ascites within 4 months postoperatively * ≥4 months since surgery

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Conditions

The condition(s) this trial relates to.

carcinoma of gallbladder and extrahepatic biliary tract cholangiocarcinoma extrahepatic bile duct carcinoma gallbladder carcinoma gallbladder neoplasm

As listed by the trial registrant

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

Extrahepatic cholangiocarcinoma and gallbladder carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.