Treatment for potentially resectable biliary tract cancers using a combination of drugs
Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
This study is testing a combination of three drugs to see if they can help people with newly diagnosed biliary tract cancers before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | chemotherapy, pembrolizumab |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06001658 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of using a combination of gemcitabine, cisplatin, and pembrolizumab in patients with newly diagnosed, potentially resectable biliary tract cancers. The approach focuses on administering these drugs perioperatively to assess their effectiveness in achieving pathologic responses. Patients will be monitored for safety and measurable disease outcomes as defined by RECIST criteria. The study aims to provide insights into the potential benefits of this combination therapy for biliary tract cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed, biopsy-proven biliary tract cancer that is deemed resectable.
Not a fit: Patients with unresectable biliary tract cancer or those with significant comorbidities that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with biliary tract cancers.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in various cancers, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Baltimore, Maryland
- SKCCC Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Marina Baretti, M.D. — SKCCC Johns Hopkins Medical Institution
- Study coordinator: Colleen Apostal, RN
- Email: GIClinicalTrials@jhmi.edu
- Phone: 410-614-3644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.