OncoMatch/Clinical Trials/NCT06192797
Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
Is NCT06192797 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06192797 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.
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