A prospective randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE with epirubicin for patients with hepatocellular carcinoma

Phase 2

• Conditions: Patients with hepatocellular carcinoma who are scheduled to underwent TACE

• Registration Number: JPRN-UMIN000030822
• Lead Sponsor: agoya University Hospital Department of Gastroenterology and Hepatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

1. Extrahepatic metastasis. 2. Ruptured HCC nodules in which TACE is planned. 3. Prior surgical reconstruction or endoscopic treatment of the biliary tract. 4. Severe arterio portal or arterio venous shunts in the liver. 5. Refractory ascites or pleural effusion. 6. Allergy to contrast medium that precludes angiography. 7. Previously registered patients in this study. 8. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception. 9. Comorbid diseases as cardiac failure, recent myoinfarction, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders, and serious allergy to medicine. 10. Not eligible because of safety issues judged by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor Response at 3 month after TACE

Secondary Outcome Measures

Name	Time	Method
Adverse events