NCT03864211

Thermal Ablation Followed by Immunotherapy for HCC

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
PROCEDURE	Thermal ablation	Radiofrequency ablation or microwave ablation is performed under CT or ultrasound guidance for one to five target lesions.
DRUG	Toripalimab	Protocol 1. Patients received toripalimab (240mg, Q3W) as monotherapy. Protocol 2. Patients received toripalimab (240mg, Q3W) on day 3 after ablation. Protocol 3. Patients received toripalimab (240mg, Q3W) on day 14 after ablation.

Timeline

• Start date: 2019-06-15
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2019-03-06
• Last updated: 2022-09-29

Locations

1 site across 1 country: China