NCT06841185View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

656

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

June 6, 2027

Study Completion Date

May 5, 2028

Conditions
Hepatocellular Carcinoma (HCC)
Interventions
DRUG

HLX13

HLX13 (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles

DRUG

US-sourced YERVOY®

US-sourced YERVOY® (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles

DRUG

EU-sourced YERVOY®

EU-sourced YERVOY® (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY