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New combo therapy aims to shrink unresectable bile duct tumors

NCT ID NCT07364305

Disease control Sponsor: Eastern Hepatobiliary Surgery Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a treatment for people with advanced bile duct cancer (ICC) that cannot be removed by surgery. The treatment combines chemotherapy given directly into the liver (HAIC) with immunotherapy drugs. The goal is to see if this combination can shrink tumors enough to allow surgery or improve outcomes. About 50 participants will be enrolled.

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 50 people

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

Started

Jan 2025

Expected to finish

Jan 2028

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

Accepted

You do not need to have the condition being studied to take part.

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. Age: Age ≥ 18 years old. 2. Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging. 3. Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria). 4. Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1. 5. Expected lifespan: Expected lifespan ≥ 3 months. 6. Liver function: Child Pugh classification A or B. 7. Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol. 8. Not receiving relevant treatment: Not receiving systematic treatment for ICC. Exclusion Criteria: 1. Previous treatment: Previously received systemic treatment for ICC. 2. Poor physical condition: ECOG physical condition score ≥ 2. 3. Poor liver function: Child Pugh grading\>8. 4. Short life expectancy: Life expectancy is less than 3 months. 5. Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors. 6. Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys. 7. Drug allergy or intolerance: Allergic to the investigational drug or its excipients. 8. Other: Other situations that the researcher deems unsuitable to participate in this study

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Conditions

The condition(s) this trial relates to.

cancer intrahepatic cholangiocarcinoma

As listed by the trial registrant

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

Advanced cancer ICC

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

  • Shanghai Eastern Hepatobiliary Surgery Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200438, China

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