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Brief Title: HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure
Official Title: HAIC Combined With Second-line "Target Immunity" for Advanced Hepatocellular Carcinoma With Low Response or Failure of TACE Combined With First-line "Target Immunity": A Prospective, Randomized- Control, Multicenter Clinical Trial
Study ID: NCT05233358
Brief Summary: This study is a prospective, randomized controlled, multicenter clinical study. The purpose of this study is to explore the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with second-line regorafenib and immune checkpoint inhibitors in the treatment of transarterial chemoembolization (TACE) combined with first-line molecular targeted drugs and immune checkpoint inhibitors with low response or failure in advanced hepatocellular carcinoma.
Detailed Description: This is a randomized, open, parallel-controlled, multi-center clinical trial with a type of comparison using a merit test. This study will recruit 176 patients with advanced liver cancer who have received TACE combined with first-line "target immune" therapy and were rated as low response or treatment failure according to mRECIST criteria in multiple research centers across the country. Subjects randomly assigned to the experimental group will receive HAIC in combination with regorafenib and immune checkpoint inhibitors, and subjects randomly assigned to the control group will receive TACE in combination with regorafenib and immune checkpoint inhibitors.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Liyun Zheng, MD.
Affiliation: The Central Hospital of Lishui City
Role: STUDY_DIRECTOR