NCT05582109

Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma

A Single-arm, Open-label, Prospective, Phase II Clinical Study of Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TACE lays a theoretical foundation for synergistic enhancement in combination with PD-1/PD-L1 immunosuppressive agents by reducing tumor burden and peripheral blood treg, improving the immune status of patients, reducing immune tolerance, and enhancing anti-tumor effects. TACE then causes locally treated tumor cell death and releases tumor-specific antigens, which further induce tumor-associated antigen-specific responses due to this immunogenic cell death (ICD), thereby activating the immune system to attack tumor cells. This is a single-arm, open-label, exploratory clinical study to evaluate the efficacy and safety of Envafolimab, Lenvatinib combined with TACE in the treatment of unresectable locally advanced hepatocellular carcinoma.

Conditions

• Objective Response Rate (ORR)

Interventions

Type	Name	Description
DRUG	Envafolimab, Lenvatinib Combined With TACE	PD-L1 inhibitor

Timeline

• Start date: 2022-10-30
• Primary completion: 2023-10-30
• Completion: 2025-10-30
• First posted: 2022-10-17
• Last updated: 2022-10-17