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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.

Phase 2RecruitingTongji HospitalNCT06192797Data as of May 2026

Treatment: Lenvatinib plus pucotenlimabThis 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.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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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