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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05967182 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.
What disease stage is eligible?
Stage IB or II or IIIA or IIIB is required.
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 qualifyRelated pages