OncoMatch/Clinical Trials/NCT06187961
HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma
Is NCT06187961 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Lenvatinib and Cadonilimab for hepatocellular carcinoma non-resectable.
Treatment: Lenvatinib · Cadonilimab — This is an open-label, single-arm, phase 2 study evaluating hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and cadonilimab as conversion therapy for initially unresectable hepatocellular carcinoma (HCC). The primary objective is to assess the conversion rate, defined as the proportion of participants who are deemed amenable to curative-intent treatment by the multidisciplinary team (MDT), including R0 resection, curative ablation, or liver transplantation, after study treatment. Secondary objectives include curative-intent intervention rate, tumor response, survival outcomes, safety, pathological response, and exploratory tissue and blood biomarkers.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC STAGE B, BCLC STAGE C (other)
Not suitable for curative-intent treatment (including radical hepatic resection, liver transplantation, or curative ablation)... BCLC stage B or C.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor treatment for hepatocellular carcinoma
No prior systemic anti-tumor treatment for hepatocellular carcinoma before the first dose.
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1, anti-PD-L1/L2, anti-CTLA-4, or other immunotherapy
Cannot have received: anti-PD-L1 therapy
Prior treatment with anti-PD-1, anti-PD-L1/L2, anti-CTLA-4, or other immunotherapy
Cannot have received: anti-PD-L2 therapy
Prior treatment with anti-PD-1, anti-PD-L1/L2, anti-CTLA-4, or other immunotherapy
Cannot have received: anti-CTLA-4 therapy
Prior treatment with anti-PD-1, anti-PD-L1/L2, anti-CTLA-4, or other immunotherapy
Cannot have received: immunotherapy
Prior treatment with anti-PD-1, anti-PD-L1/L2, anti-CTLA-4, or other immunotherapy
Cannot have received: targeted therapy against VEGF/VEGFR, RAF, MEK, PDGFR, FGFR, or related pathways
Prior targeted therapy against VEGF/VEGFR, RAF, MEK, PDGFR, FGFR, or related pathways
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L; platelet count ≥75×10^9/L; hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min; urine protein <2+; if urine protein ≥2+, 24-hour urinary protein must be <1 g
Liver function
Total bilirubin ≤2× ULN; ALT and AST ≤5× ULN; serum albumin ≥28 g/L; alkaline phosphatase ≤5× ULN; Child-Pugh score ≤7
Cardiac function
INR ≤2.3 or prothrombin time prolongation ≤6 seconds; left ventricular ejection fraction <50% [excluded]; symptomatic congestive heart failure (NYHA class II-IV) [excluded]; symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome, or screening QTc >500 ms by Fridericia formula [excluded]
Adequate organ and bone marrow function within 7 days before enrollment: ... Child-Pugh score ≤7. See full criterion for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06187961 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 BCLC STAGE B or BCLC STAGE C 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