NCT04663035

Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC

CT-guided Thermal Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage Hepatocellular Carcinoma: a Randomized Controlled Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ming Zhao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.

Detailed description

Ablation is one of the main treatments for early recurrent HCC, and its immune stimulation is expected to improve the efficacy of anti-PD-1 immune checkpoint inhibitor therapy. Tislelizumab is a new immunotherapy agent with independent intellectual property rights in China, which is highly efficient and safe. It is of great value to combine Tislelizumab with ablation to reduce the risk of recurrence in HCC patients. In this study, early-stage HCC patients with high risk of recurrence would be included and randomly assigned to receive ablation plus Tislelizumab or ablation alone. The tumor recurrence, overall survival and safety would be observed and recorded to analyze whether Tislelizumab can reduce the recurrence rate.

Conditions

• Recurrent Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	200mg, iv. drip, Q3W. Tislelizumab will start within 3-7 days after ablation treatment. The longest course of treatment is 12 months.
PROCEDURE	Ablation	After local anesthesia and intravenous sedative injection, the unipolar needle would be gradually inserted into the lesion and placed on the deepest edge of the lesion. The ablation electrode is a unipolar needle with a bare end of 2 or 3 cm (adjusted to tumor size). The ablation power is 150 watts (range from 100 to 200 watts). In general, the average ablation time for each lesion is about 12 minutes (ranging from 10 to 15 minutes).

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-12-18
• Completion: 2025-12-18
• First posted: 2020-12-10
• Last updated: 2023-03-22

Locations

1 site across 1 country: China