drugset / Trial / NCT01906216

Sorafenib Chemoembolization Evaluation Controlled Trial

NCT01906216

Phase 3 Completed 199 enrolled Air Force Military Medical University, China
RandomizedParallel-groupSingle-blindTreatment

Summary

This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the prognostic factors that influence the survival. Data on the efficacy and safety of sorafenib in combination with TACE in patients with advanced HCC are lacking. Because in western countries, advanced HCC is considered as a contraindication for TACE treatment. However, clinical practice patterns differ markedly between Asia and western countries: in Asia TACE is performed in selected advanced HCC patients. We consider sorafenib combined with TACE could achieve better survival benefit than sorafenib alone in selected advanced HCC patients.

Timeline

Start
2013-09
Primary completion
2022-06-30
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 400 mg Oral