drugset / Trial / NCT02240771

Transarterial Chemotherapy Compared With Oral Chemotherapy in the Treatment of Advanced Hepatocellular Carcinoma

NCT02240771

RandomizedParallel-groupOpen-labelTreatment

Summary

In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at presentation and hence are unsuitable for the available curative treatment options. In such patients the treatment options are mainly palliative. Transarterial chemoembolization (TACE), transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only available options currently. Many patients have more advanced disease with the involvement of branches of portal vein. This further limits the therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any standard form of therapy. TAC and oral chemotherapy has been tried in this group of patients by few researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for advanced stage (BCLC C) needs to be explored. However, there are no randomized controlled trials (RCT's) available. TAC is the procedure for treating patients of HCC with portal vein invasion where only the chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent embolization of the feeding vessels. In order to select a modality which would produce better outcomes in advanced HCC patients (BCLC C), this study was planned.

Timeline

Start
2006-01
Primary completion
2014-12
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1500 mg Oral
Comparator Thalidomide Other / unclassified 300 mg Oral