A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate

A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate - A randomized controlled trial of selective DEB-TACE vs. cTACE for HCC (JIVROSG-1302:PRESIDENT study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021250

Enrollment

200

Registered

2016-03-01

Start date

2016-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hepatocellular carcinoma who are scheduled to receive selective TACE

Interventions

TACE with Drug eluting beads of epirubicin TACE with gelatine particle and emulsion of lipiodol and epirubicin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or clinically diagnosed hepatocellular carcinoma 2. No indication for surgical resection, liver transplantation, or local ablation therapy 3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection and possible to perform selective TACE 4. No previous treatment for HCC nodules in which TACE is planned 5. Measurable HCC nodules in which TACE is planned 6. Maximum HCC nodule of 5cm or less in which TACE is planned 7. ECOG Performance Status 0-1 8. Child-Pugh A or B 9. Adequate organ function a. T-Bil<=3.0 mg/dL b. AST/ALT within 5 times of upper normal limit or 250 IU/L 10. Age of 20 years or over 11. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Tumor thrombosis in portal vein 2. Extrahepatic metastasis 3. Ruptured HCC nodules in which TACE is planned 4. Extrahepatic feeding arteries for HCC nodules in which TACE is planned 5. Prior surgical reconstruction or endoscopic treatment of the biliary tract 6. Clinically significant refractory ascites or pleural effusion 7. Severe arterio-portal or arterio-venous shunts in the liver 8. Allergy to contrast medium that precludes angiography 9. Previously registered patients in this study 10. Severe, active co-morbidity 11. 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 12. Not eligible because of safety issues judged by investigators

Design outcomes

Primary

Measure	Time frame
local complete response rate of treated lesion by selective TACE at 3 month after TACE	—

Secondary

Measure	Time frame
local complete response rate of treated lesion by selective TACE at 1 month after TACE, Adverse events, serious adverse events	—

Countries

Japan

Contacts

Public ContactMasafumi Ikeda

National Cancer Center Hospital East Department of hepatobiliary & pancreatic oncology

masikeda@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026