drugset / Trial / NCT02755311

Liver Resection Versus Transarterial Chemoembolization for the Treatment of Intermediate-stage Hepatocellular Carcinoma

NCT02755311

Phase 3 Unknown 198 enrolled Sun Yat-sen University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The role of transarterial chemoembolization (TACE) as the standard therapy for intermediate-stage hepatocellular carcinoma (HCC) is being challenged by increasing studies which showed that liver resection (LR) is a safe and feasible procedure with better survival outcomes than TACE does. In light of this, the investigators have constructed a Markov model to simulate comparing LR and TACE in the treatment of intermediate-stage HCC. The results suggested that LR may provide survival benefit over TACE for the treatment of intermediate-stage HCC in cirrhotic patients. However, validating the simulated result by a study with higher quality (e.g. prospective clinical trial) would be of great value in providing a more convincing finding. Therefore, based on the established Markov model, the investigators aimed to prospectively compare the treatment efficacy and safety of LR with TACE for consecutive patients with intermediate-stage HCC.

Timeline

Start
2014-03
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 300 mg Other
Comparator Epirubicin Small molecule 50 mg Other
Comparator Epirubicin Small molecule 100 mg Other
Comparator Hydroxycamptothecin Small molecule 10 mg Other
Comparator Hydroxycamptothecin Small molecule 30 mg Other
Comparator Pirarubicin Small molecule 30 mg Other
Comparator Pirarubicin Small molecule 50 mg Other
Comparator fluorouracil Small molecule 500 mg Other
Comparator fluorouracil Small molecule 1000 mg Other
Comparator lipiodol Unknown 5 ml Other