Thermal Ablation Followed by Immunotherapy for HCC

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title: Phase I/II Study of Thermal Ablation Followed by Toripalimab in Unresectable Hepatocellular Carcinoma

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of immunotherapy toripalimab (anti-PD-1 mAb) combined with thermal ablation in patients with Hepatocellular Carcinoma (HCC).

Clinical Trial Description

1.1 Primary Objective & Hypothesis Determine the safety and efficacy of radiofrequency ablation (RFA)/microwave ablation (MWA) followed by toripalimab for advanced HCC by establishing the rates of toxicity that occur within 6 months after ablation. Hypothesis: Thermal ablation followed by toripalimab will have similar toxicity to toripalimab monotherapy. Thermal ablation enhances antitumor immune response and improves the best overall response rate compared to historical controls with toripalimab alone. 1.2 Secondary Objectives and Hypotheses Estimate the progression-free survival, and overall survival. Hypothesis: Disease control and survival will be better than that observed with toripalimab monotherapy. 1.3 Exploratory Objectives Explore changes in inflammatory biomarkers (including, but not limited to CD8+/Treg ratio, total CD4+ counts, total lymphocyte count) in pretreatment and on-treatment serially collected peripheral blood samples. Hypothesis: Changes in inflammatory biomarkers after thermal ablation may correlate with a more favorable response to immunotherapy. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

• NCT number: NCT03864211
• Study type: Interventional
• Source: Xiangya Hospital of Central South University
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 15, 2019
• Completion date: May 30, 2023