Phase II Study to Evaluate the Safety and Effectiveness of HLX53 Combined with Serplulimab and HLX04 Compared to Placebo Plus Serplulimab and HLX04 in Patients with Untreated Advanced or Metastatic Hepatocellular Carcinoma

What this Trial Is About

Researchers are studying the best dosage and evaluating how well and how safely Serplulimab Injection HLX10, a Recombinant Anti-PD-1 Antibody and HLX04 a biosimilar to Bevacizumab work, with or without HLX53 an Anti-TIGIT Fc Fusion Protein, in patients who have untreated, locally advanced, or metastatic hepatocellular carcinoma. This study is a Phase II randomized, double-blind, multi-center trial focused on these treatments in patients with this type of liver cancer. Participants receive one of three treatments every three weeks either HLX53 at 1000 mg or 2000 mg combined with HLX10 and HLX04, or a placebo combined with HLX10 and HLX04. All drugs are given through intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until unacceptable side effects occur or until the treatment no longer benefits the patient as judged by the investigator. During the study, patients are monitored closely for tumor response and progression using measures such as objective response rate ORR and progression-free survival PFS over up to 14 months, as well as overall survival up to about 36 months. Safety is assessed by tracking any adverse events for up to 24 months. Patients will undergo clinical evaluations, imaging scans, and laboratory tests throughout the study to assess treatment effects and side effects.

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.