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A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

StatusNot Yet Recruiting
PhasePhase 3
Started2025-04-30
View on ClinicalTrials.gov ↗
This is a multicenter, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the efficacy, safety, PK, and immunogenicity of HLX13 and YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
Trial Details
NCT Number NCT06841185
Lead Sponsor Shanghai Henlius Biotech
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 656 participants
Start Date 2025-04-30
Primary Completion 2027-06-06 (estimated)
Study Completion 2028-05-05 (estimated)
Updated on ClinicalTrials.gov 2025-02-24