OncoMatch/Clinical Trials/NCT05967182
A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
Is NCT05967182 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Gemcitabine for cholangiocarcinoma.
Treatment: Pembrolizumab · Gemcitabine · Cisplatin — To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after surgery, compared to treatment with surgery and standard chemotherapy alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage IB, II, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
Cannot have received: systemic therapy
Has had previous systemic therapy for ICC.
Cannot have received: systemic anti-cancer therapy including investigational agents
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
Cannot have received: radiotherapy
Exception: 1-week washout permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 9 g/dL with or without transfusions; Platelets ≥ 100 x 10^9/L without transfusions
Kidney function
Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 50mL/min at screening
Liver function
ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases; Total bilirubin ≤ 1.5 × ULN and < 2 mg/dL (exceptions for indirect bilirubin ≤ 1.5 × ULN or non-hepatic cause); INR, PT, aPTT ≤1.5 × ULN unless on anticoagulant therapy and within therapeutic range
Adequate hematologic status: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL with or without transfusions; Platelets (PLT) ≥ 100 x 10^9/L without transfusions. Adequate liver function: ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases; Total bilirubin ≤ 1.5 × ULN and < 2 mg/dL (exceptions for indirect bilirubin ≤ 1.5 × ULN or non-hepatic cause); INR, PT, aPTT ≤1.5 × ULN unless on anticoagulant therapy and within therapeutic range. Adequate renal function: Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 50mL/min at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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