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New drug combo offers hope for advanced gallbladder cancer patients

NCT ID NCT07310069

Disease control Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new combination of chemotherapy and two immunotherapy drugs in people with advanced gallbladder cancer that cannot be removed by surgery. The goal is to see if the treatment can shrink tumors enough to allow surgery or improve response. About 44 adults aged 18-75 with good organ function may join.

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 44 people

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

Started

May 2025

Expected to finish

Dec 2027

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 75 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: * Signed informed consent. * Age 18-75 years. * ECOG performance status 0-2, Child-Pugh class A. * Histologically or cytologically confirmed advanced gallbladder cancer, deemed unresectable for R0 resection. * Adequate organ function: * ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L. * Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min. * Total bilirubin ≤1.5×ULN (≤3×ULN if liver metastases); AST/ALT ≤3×ULN (≤5×ULN if liver metastases). * Life expectancy ≥3 months. * Non-pregnant, non-lactating women and willingness to use contraception during and for 3 months after treatment. Exclusion Criteria: * Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disease, psychiatric disorders); active autoimmune disease requiring medication. * Known allergy or intolerance to chemotherapy agents. * Prior antitumor therapy (chemotherapy, radiotherapy, immunotherapy) within the past year, or history of other malignancies (except cured cervical carcinoma in situ or non-melanoma skin cancer). * Pregnancy, lactation, or unwillingness to use contraception. * Participation in another clinical trial within 30 days before the first dose. * Unwillingness to participate or inability to provide informed consent. * Any other condition that, in the investigator's judgment, may affect patient safety or compliance

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Conditions

The condition(s) this trial relates to.

gallbladder cancer gallbladder carcinoma gallbladder neoplasm

As listed by the trial registrant

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

Gallbladder cancer unresectable

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Xinhua hospital

    Shanghai, Shanghai Municipality, 200092, China

More trials for these conditions

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