Spots Global Cancer Trial Database for Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC
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Trial Identification
Brief Title: Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC
Official Title: CT-guided Thermal Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage Hepatocellular Carcinoma: a Randomized Controlled Phase II Clinical Trial
Study ID: NCT04663035
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,, Guangzhou, Guangdong, China
Contact Details
Name: Ming Zhao, MD
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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