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

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborator: Indian Council of Medical Research
• Treatments: Capecitabine; Thalidomide

Criteria

Inclusion Criteria:

• Patients above 12 years of age with performance status (PST) score of 0-2

• Unresectable HCC with underlying Child's A/B cirrhosis

• Blocked Main portal vein

• No history of drug allergy

• Informed written consent of patient.

Exclusion Criteria:

• Child's C cirrhosis

• Performance status 3-5

• Extra hepatic disease

• Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc

• Previous history of encephalopathy/ upper gastrointestinal bleed in the last six months

• Pregnancy