OncoMatch/Clinical Trials/NCT05408221
the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma
Is NCT05408221 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies Rulonilimab+Lenvatinib for hepatocellular carcinoma.
Treatment: Rulonilimab+Lenvatinib — There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic chemotherapy
Subjects have not received any systemic therapy for HCC previously (mainly including systemic chemotherapy, anti-angiogenic drugs or other molecular targeted therapy, antibodies/drugs targeting T cell co-regulatory proteins (such as anti-CTLA-4, anti-PD-1 /PD-L1, anti-OX-40, anti-CD137, anti-TIM-3, anti-LAG-3 antibodies, etc.)
Lab requirements
Blood counts
neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin (HGB) ≥90g/L, platelet count (PLT) ≥75×10^9/L
Kidney function
serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min
Liver function
Child-Pugh score A or B (≤7); Total bilirubin ≤2×ULN, ALT and AST≤5×ULN; serum albumin ≥29g/L
Cardiac function
LVEF (left ventricular ejection fraction) < 50% [excluded]; QTc interval ≥480ms [excluded]
Child-Pugh score A or B (≤7); Blood test: neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin (HGB) ≥90g/L, platelet count (PLT) ≥75×10^9/L; liver function: Total bilirubin ≤2×ULN, ALT and AST≤5×ULN; kidney function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min; serum albumin ≥29g/L; LVEF (left ventricular ejection fraction) < 50% [excluded]; QTc interval ≥480ms [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05408221 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.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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