drugset / Trial / NCT04143191

Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC

NCT04143191

Phase 3 Unknown 158 enrolled Sun Yat-sen University
RandomizedParallel-groupSingle-blindPrevention

Summary

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.

Timeline

Start
2019-09-15
Primary completion
2021-09-15
Completion
2023-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 400 mg Oral