Can a Pre-Surgery drug combo boost bile duct cancer survival?

NCT ID NCT06923475

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial is investigating whether giving a combination of chemotherapy and immunotherapy before surgery, and continuing immunotherapy after, can improve outcomes for people with a rare and aggressive type of bile duct cancer. Participants will be randomly assigned to receive either the standard approach of surgery first or the new approach with treatment before and after surgery. The study aims to see if the pre-surgery treatment helps reduce the chance of the cancer coming back and improves overall survival.

What this could mean

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

Active substance
A combination of two chemotherapy drugs (gemcitabine and cisplatin) plus an immunotherapy drug (pembrolizumab) given before and after surgery
What this could lead to
If successful, this approach could improve survival and reduce recurrence for people with bile duct cancer, potentially making surgery more effective.
What could go wrong
This is a mid-to-late-stage trial, but results are not guaranteed. The added treatment may cause more side effects and may not improve outcomes for all patients.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 150 people

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

Started

Apr 2026

Expected to finish

Nov 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 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: * Histologically or cytologically confirmed resectable or borderline resectable pCCA and dCCA. These are all the patients considered candidates for upfront surgical exploration, with intent to resect, as confirmed by local MDT and the study expert panel also taking into consideration endoscopic and radiological findings. In cases where drainage is not required, patients with a disease highly suspicious for extrahepatic cholangiocarcinoma, as determined by the expert MDT, may be included without histological proof to prevent unnecessary post-ERCP complications. * Successful drainage, in case of clinical significant bile duct obstruction. * MidCCA inclusion in the NEODISCO-trial will be permitted and will be included according to the proposed type of resection. * Male/female participants who are at least 18 years of age on the day of signing informed consent. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. Exclusion Criteria: * Upfront "clearly" unresectable pCCA: circumferential unreconstructable vascular involvement of the FLR and/or insufficient FLR for potential radical resection. Insufficient FLR is defined as \<30% residual volume or a function \<2.7 min/m2. Patients considered borderline resectable but, by the discretion of the MDT, not a candidate for upfront exploration/resection, are considered ineligible for NEODISCO. * Upfront clearly unresectable dCCA (following DPCG criteria). * Patients with proven N2 lymph nodes (according to the AJCC 8th edition). * PCCA eligible for liver transplantation. * Intrahepatic cholangiocarcinoma with hilar involvement. * Cancer suspicious for ampullary carcinoma (for instance involvement of papilla during endoscopy). * Local recurrence following prior resection of eCCA (patients who develop local recurrence during the study are however not excluded). * Patients with underlying liver diseases: PSC, untreated hepatitis, cirrhosis child-Pugh B, C. * Previous malignancy unless no evidence of disease, or diagnosed more than 3 years before diagnosis of eCCA, or with a life expectancy of more than 5 years from date of inclusion. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, Netherlands

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