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Study of Gemcitabine, Cisplatin, and Pembrolizumab for Biliary Tract Cancers

This study is looking at a combination of three medicines—gemcitabine, cisplatin, and pembrolizumab—for people with newly diagnosed, resectable biliary tract cancer (cancer of the bile ducts). The goal is to see if this combination is safe and effective in shrinking tumors before and after surgery. You would receive these medications intravenously (through a vein) in cycles, both before and after your surgery. Researchers will examine tumor samples to see how well the treatment worked. This study is currently recruiting about 27 participants and is open to adults aged 18 and older with specific types of biliary tract cancer.

Study design
This is an interventional study with a planned enrollment of 27 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive intravenous treatments of gemcitabine, cisplatin, and pembrolizumab in cycles before and after surgery. The exact number of visits and procedures is not detailed.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure a specific response in your tumor samples, with results being assessed at 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06001658

Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~27 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:GemcitabineCisplatinPembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average minimum Euclidean distance from CD8+ T cells to immunosuppressive tumor-associated macrophages (TAMs) at the per-cell level in patients with a major pathologic response versus pathologic non-responders.
Measured over 4 years

Conditions

Billiary Track Cancer

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NCT06001658

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • SKCCC Johns Hopkins

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Marina Baretti, M.D. · PRINCIPAL_INVESTIGATOR · SKCCC Johns Hopkins Medical Institution

Who to contact

Colleen Apostal, RN
[email protected]
410-614-3644
Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Average minimum Euclidean distance from CD8+ T cells to immunosuppressive tumor-associated macrophages (TAMs) at the per-cell level in patients with a major pathologic response versus pathologic non-responders.4 years

    The evaluable population of this endpoint consist of all patients who receive at least one dose of study drug and have TAMs and CD8 T cell measures at the time of surgery. TAMs being evaluated are the following: immunosuppressive TAMs with high Arginase-1 expression (CD68+CD163+Arg-1hiPDL1-/+), immunosuppressive TAMs with low Arginase-1 expression (CD68+CD163+Arg-1lo PDL1-/+), and less immunosuppressive TAMs (CD68+CD163-HLA-DRhi/CD86hi/PDL1hi)