Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Anti-Inflammatory drug may boost cancer therapy in bile duct cancer

NCT ID NCT07632235

Disease control Sponsor: Shanghai 6th People's Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study tests whether adding the anti-inflammatory drug celecoxib to standard immunotherapy and chemotherapy can help people with advanced bile duct cancer live longer without their disease getting worse. The trial focuses on patients whose tumors have high levels of a marker called CK5/6. About 112 participants will be randomly assigned to receive either the standard treatment or the standard treatment plus celecoxib. The study is currently recruiting.

What this could mean

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

Active substance
celecoxib (an anti-inflammatory drug) plus pembrolizumab (immunotherapy) and gemcitabine/cisplatin (chemotherapy)
What this could lead to
If successful, this could offer a more effective, personalized treatment option for people with a specific type of advanced bile duct cancer.
What could go wrong
This is an early-phase trial with a small number of participants. Adding celecoxib may not improve outcomes and could increase side effects like kidney or heart problems.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 112 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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 years and older

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: * Age ≥ 18 years. * Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA). * Unresectable locally advanced, recurrent, or metastatic disease. * No prior systemic therapy for advanced disease. * At least one measurable lesion according to RECIST v1.1. * ECOG performance status of 0-1. * Availability of adequate pre-treatment tumor tissue for central pathological review. * CK5/6 H-score \> 1.0 as determined by central laboratory testing. * Adequate organ and bone marrow function as defined by protocol-specified laboratory criteria. * Patients with biliary obstruction must have undergone effective drainage and achieved clinical stabilization prior to enrollment. * Ability to provide written informed consent. Exclusion Criteria: * Other primary malignancies including extrahepatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma. * CK5/6 H-score ≤ 1.0. * Prior systemic therapy for advanced or metastatic disease. * Active gastrointestinal bleeding, peptic ulcer disease, or high risk of gastrointestinal perforation. * Recent history of significant cardiovascular events including myocardial infarction, stroke, uncontrolled hypertension, or severe heart failure. * Known hypersensitivity to celecoxib, sulfonamides, NSAIDs, or aspirin-exacerbated respiratory disease. * Active autoimmune disease or conditions contraindicating pembrolizumab therapy. * Severe renal impairment. * Child-Pugh class C hepatic impairment. * Active uncontrolled infection. * Any condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Intrahepatic cholangiocarcinoma (ICC) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension intrahepatic cholangiocarcinoma

As listed by the trial registrant

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

Intrahepatic cholangiocarcinoma (ICC)

How to take part

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

  1. The places running it

    5 sites. 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

  • Renji Hospital

    Shanghai, China

  • Shanghai 10th People's Hospital

    Shanghai, China

  • Shanghai Sixth People's Hospital

    Shanghai, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, China

  • Wuhan TongJi Hospital

    Wuhan, China

More trials for these conditions

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