Transcatheter Arterial Chemo-Embolization (TACE) vs. Sorafenib in Patients with Hepatocellular Carcinoma Refractory to TACE: A Randomized Phase II Trial

Phase 2

• Conditions: Hepatocellular carcinoma

• Registration Number: JPRN-UMIN000009921
• Lead Sponsor: The University of Tokyo, Department of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who received sorafenib or molecular target drug in the past 3 months. 2.Patients receiving the treatment (other than study drug or procedure) for HCC. 3.Patients who have an allergic history to the study drug. 4.Patients during pregnancy, breast-feeding, or at risk of becoming pregnant. 5.Patients without indication for TACE. 6.Patients on dialysis. 7.Patients with poorly-controlled hypertension (systolic blood pressure > 170mmHg on medication) 8.Patients with esophageal varices who have a risk for bleeding, or the patients with the history of gastrointestinal hemorrhage within a month. 9.Patients with current or past history of hepatic encephalopathy. 10.Patients with a history of liver transplantation. 11.Patients receiving drugs that affect CYP3A4 or UGT1A9 (e.g.Rifampicin). 12.Patients with other primary malignancies. 13.Patients infected with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). 14.Patients considered inappropriate by the study investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified