OncoMatch/Clinical Trials/NCT06001658
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Is NCT06001658 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Cisplatin for billiary track cancer.
Treatment: Gemcitabine · Cisplatin · Pembrolizumab — The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Performance status
ECOG OR KARNOFSKY 0–1
ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
Prior therapy
Cannot have received: systemic chemotherapy
Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
Cannot have received: anti-PD-1 therapy
Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
Cannot have received: anti-PD-L1 therapy
Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
Cannot have received: radiation therapy
Exception: allowed if completed >2 weeks before start of study intervention
Has received prior radiotherapy within 2 weeks of start of study intervention.
Lab requirements
Blood counts
adequate organ and marrow function defined by study-specified laboratory tests
Kidney function
adequate organ and marrow function defined by study-specified laboratory tests
Liver function
adequate liver function defined by study-specified laboratory tests
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- SKCCC Johns Hopkins · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06001658 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify