OncoMatch/Clinical Trials/NCT06001658
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Is NCT06001658 recruiting? Yes, currently enrolling (May 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
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
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