NCT03973112

A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

A Single-arm, Open, Multicenter, Phase II Clinical Study Evaluating the Use of HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) in Combination With HLX04 (Recombinant Anti-vegf Humanized Monoclonal Antibody Injection) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-arm, open, multicenter phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX10 + HLX04 intravenous infusion, every two weeks, lose treatment until clinical benefit, toxicity, the subjects of the resistance or the doctor decided to suspend the treatment, tested subjects death revocation of informed consent, subjects, subjects of pregnancy, not to plan or program requirement from, or management reasons, treatment for up to 2 years (before).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	HLX10 3mg/kg	anti-PD-1
DRUG	HLX04 5mg/kg	anti-VEGF, a biosimilar to Avastin
DRUG	HLX04 10mg/kg	anti-VEGF, a biosimilar to Avastin

Timeline

• Start date: 2019-09-24
• Primary completion: 2022-06-15
• Completion: 2022-12-15
• First posted: 2019-06-04
• Last updated: 2022-01-12

Locations

1 site across 1 country: China