New drug combo aims to shrink bile duct tumors before surgery
NCT ID NCT06001658
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a mix of two chemotherapy drugs (gemcitabine and cisplatin) plus an immunotherapy drug (pembrolizumab) before and after surgery is safe and helps shrink tumors in people with biliary tract cancer. About 27 adults with resectable cancer will take part. Researchers will check how the immune system responds inside the tumor and track side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma. * Resectable BTC (biliary tract cancer) * Measurable disease per RECIST 1.1 as determined by the investigator. * Age ≥18 years. * ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80 * Patients must have adequate organ and marrow function defined by study-specified laboratory tests. * Patients must have adequate liver function defined by study-specified laboratory tests. * Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test. * For both Women and Men, must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC. * Has received prior radiotherapy within 2 weeks of start of study intervention. * Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1. * Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study's investigational drugs. * Has a known history of Human Immunodeficiency Virus (HIV)/AIDS * Has active co-infection with HBV and HDV. * Has a diagnosis of immunodeficiency. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Systemic or topical corticosteroids at immunosuppressive doses. * Prior allogeneic stem cell transplantation or organ transplantation. * Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants. * Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements. * Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements. * Evidence of clinical ascites. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations. * Pregnant or breastfeeding. * WOCBP and men with female partners (WOCBP) who are not willing to use contraception. * Subjects unable to undergo venipuncture and/or tolerate venous access. * Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
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Genom att skicka in godkänner du våra Användarvillkor
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
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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SKCCC Johns Hopkins
RECRUITINGBaltimore, Maryland, 21231, United States
Contact Email: •••••@•••••
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