OncoMatch/Clinical Trials/NCT06192797
Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
Is NCT06192797 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lenvatinib plus pucotenlimab for cholangiocarcinoma non-resectable.
Treatment: Lenvatinib plus pucotenlimab — This is an open-label, single-arm, phase 2 study. The purpose of study is to evaluate the feasibility and safety of hepatic artery infusion chemotherapy combined with lenvatinib and pucotenlimab as conversion therapy for unresectable intrahepatic cholangiocarcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Previous treatment with any anti-PD-1 antibody
Cannot have received: anti-PD-L1 therapy
Previous treatment with any anti-PD-L1/L2 antibody
Cannot have received: anti-CTLA-4 therapy
Previous treatment with any anti-CTLA-4 antibody
Cannot have received: immunotherapy
Previous treatment with any ... other immunotherapy
Cannot have received: VEGF inhibitor
Previous treatment with targeted therapy against VEGF and/or VEGFR
Cannot have received: RAF inhibitor
Previous treatment with targeted therapy against RAF
Cannot have received: MEK inhibitor
Previous treatment with targeted therapy against MEK
Cannot have received: PDGFR inhibitor
Previous treatment with targeted therapy against PDGFR
Cannot have received: FGFR inhibitor
Previous treatment with targeted therapy against FGFR
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin ≥9.0 g/dL
Kidney function
Serum Creatinine ≤ 1.5×ULN or CCr ≥50mL/min; Urinalysis proteinuria <2+; if ≥2+, 24-hour urinary protein <1g
Liver function
Total Bilirubin (TBIL) ≤2×ULN; ALT and AST ≤5×ULN; Serum albumin ≥28 g/L; ALP ≤5×ULN; Child-Pugh score ≤7
Cardiac function
Symptomatic congestive heart failure (NYHA class II-IV) and LVEF <50% excluded; symptomatic or poorly controlled arrhythmia, congenital long QT syndrome, or QTc >500 ms excluded
Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to inclusion ... Child-Pugh score less than or equal to 7. Symptomatic congestive heart failure (NYHA class II-IV), left ventricular ejection fraction (LVEF) <50% as indicated by echocardiography. Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected QTc >500 ms (calculated using the Fridericia formula) at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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