Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be beneficial for controlling intrahepatic tumour. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University
• Collaborator: Korean Liver Cancer Study Group
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Patients with hepatocellular carcinoma by the European Association for the Study of the Liver (EASL) criteria or pathology

• One or more extrahepatic metastatic lesion by proven radiologically or histologically

• No serious coagulation abnormalities

• Performance status 0 or 1 by Eastern Cooperative Oncology Group(ECOG) criteria

• Child-Pugh score 5 or 6

• Serum creatinine <1.5mg/dL

• Age between 18 ~ 75 years old

• No other life-threatening medical illness

Exclusion Criteria:

• Patients with main portal vein invasion

• Child-Pugh class B or C

• History of TACE or previous systemic chemotherapy including sorafenib

• Age >75 years old

• Cardiovascular diseases

• History of gastrointestinal bleeding within 2 weeks