NCT06537908

Anti-PD-1/PD-L1 Antibodies Plus Anti-VEGF Antibody Treatment in Patients With Advanced-Stage HCC

Phase I/II Study of Anti-PD-1/PD-L1 Antibodies Combined With Anti-VEGF Antibody Treatment in Patients With Advanced-Stage Hepatocellular Carcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to analyze the safety, tolerability, and efficacy of treatment using combination of anti-VEGF and anti-PD-1/PDL1 antibodies for patients with advanced hepatocellular carcinoma.

Detailed description

This is a study of combination anti-PD-1/PD-L1 antibodies and anti-VEGF for adult patients (≥18) with advanced hepatocellular carcinoma. Anti-VEGF (including Avastin, IBI305 etc.) is designed to block a protein called vascular endothelial growth factor, therefore blocking the blood supply that feeds the tumor. Also, Anti-VEGF has recently been shown to play a key role regulating cancer cell proliferation trough epigenetic pathway. Anti-PD-1/PD-L1 antibodies (including pembrolizumeb, nivolumab, sintilimab, toripalimab, camrelizumeb, tislelizumab and atezolizumab etc.) are given intravenously at assigned dose. Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal. This study is aimed to evaluate the safety and efficacy of the combination of anti-VEGF and PD-1/PD-L1 mAb in unresectable late-stage HCC patients.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Anti-PD-1/PD-L1 antibodies	Anti-PD-1/PD-L1 Intravenous injection for at least 6 months
DRUG	Anti-VEGF	Anti-VEGF Intravenous injection for at least 6 months

Timeline

• Start date: 2024-08-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2024-08-05
• Last updated: 2025-12-15

Locations

1 site across 1 country: China