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

Immunotherapy drug shows promise in bile duct cancer trial

NCT ID NCT04924062

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether adding the immunotherapy drug pembrolizumab to standard chemotherapy (gemcitabine and cisplatin) helps people with advanced bile duct cancer live longer. The study enrolled 158 Chinese adults with cancer that had spread or could not be removed by surgery. Researchers compared overall survival and cancer progression between those who got the immunotherapy combo and those who got a placebo plus chemo.

What this could mean

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

Active substance
pembrolizumab (an immunotherapy drug) plus gemcitabine and cisplatin (chemotherapy)
What this could lead to
If successful, this combination could become a new first-line treatment option for advanced biliary tract cancer, potentially improving survival.
What could go wrong
This is a Phase 3 trial, but results may not apply to all populations. Immunotherapy can cause immune-related side effects, and the benefit over chemo alone may be modest.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

158 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2025

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.

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 * Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer) * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator * Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria * Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion * Has a life expectancy of greater than 3 months * Has adequate organ function Exclusion Criteria * Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer) * Has ampullary cancer * Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms * Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137) * Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator * Has had an allogenic tissue/solid organ transplant

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Biliary tract carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 bile duct carcinoma bile duct neoplasm biliary tract cancer cholangiocarcinoma gallbladder neoplasm

As listed by the trial registrant

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

Biliary tract carcinoma

Contacts and locations

Locations

  • 900 Hospital of the Joint ( Site 0137)

    Fuzhou, Fujian, 350025, China

  • Anhui Provincial Hospital ( Site 0140)

    Hefei, Anhui, 230001, China

  • Beijing Cancer Hospital ( Site 0138)

    Beijing, Beijing Municipality, 100036, China

  • First Affiliated Hospital of The Third Military Medical University ( Site 0130)

    Chongqing, Chongqing Municipality, 400038, China

  • Fudan University Shanghai Cancer Center ( Site 0160)

    Shanghai, Shanghai Municipality, 201315, China

  • Fujian Provincial Cancer Hospital ( Site 0154)

    Fuzhou, Fujian, 350014, China

  • Guangdong Provincial People s Hospital ( Site 0161)

    Guangzhou, Guangdong, 510080, China

  • Harbin Medical University Cancer Hospital ( Site 0133)

    Harbin, Heilongjiang, 610000, China

  • Hunan Cancer Hospital ( Site 0132)

    Changsha, Hunan, 410013, China

  • Hunan Provincial People Hospital ( Site 0142)

    Changsha, Hunan, 410005, China

  • Peking Union Medical College Hospital ( Site 0150)

    Beijing, Beijing Municipality, 100730, China

  • Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)

    Shanghai, Shanghai Municipality, 200127, China

  • Tangdu Hospital ( Site 0146)

    Xi’an, Shanxi, 710038, China

  • The 81st Hospital of PLA ( Site 0128)

    Nanjing, Jiangsu, 210031, China

  • The First Affiliated Hospital Zhejiang University ( Site 0136)

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)

    Xi’an, Shanxi, 710048, China

  • The First Hospital of Jilin University ( Site 0131)

    Changchun, Jilin, 130021, China

  • The Third Xiangya Hospital of Central South University ( Site 0157)

    Changsha, Hunan, 410013, China

  • Tianjin Medical University Cancer Institute & Hospital ( Site 0155)

    Tianjin, Tianjin Municipality, 300060, China

  • West China Hospital of Sichuan University ( Site 0147)

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital ( Site 0134)

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital Fudan University ( Site 0129)

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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