Phase II trial of Transarterial Chemoembolization using Drug-eluting bead for advanced HCC refractory to Lipiodol-TACE

Phase II trial of Transarterial Chemoembolization using Drug-eluting bead for advanced HCC refractory to Lipiodol-TACE - TALENT study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015463

Enrollment

Registered

2014-10-17

Start date

2014-10-17

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

advanced hepatocellular carcinoma

Interventions

Transarterial chemoembolization using drug-eluting bead loaded epirubicin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or clinically confirmed hepatocellular carcinoma. 2. refractory to Lip-TACE 3. contraindication of surgery or ablation therapy 4. over 20 years old 5. BCLC stage A or B 6. Existing measurable hepatic lesion mRECIST is applicable. 7. ECOG Performance Status 0 or 1 8. Adequate organ functions: bone marrow, Heart, renal function (14 days before entry) WBC(or Neutro) =>2,500/mm3 (=>1,000/mm3) HGB =>8.5g/dl Plt >=5.0x104/mm3 T-Bil <=2.5mg/dl ALB =>2.8g/dl AST <= 5 times ULN ALT <= 5 times ULN Serum Cre <=1.5mg/dl normal ECG 9. Child-Pugh A or B 10. previous Lip-TACE less than 5 times 11. Expected survival time over 8 weeks 12. Written informed consent

Exclusion criteria

Exclusion criteria: 1) after HCC rupture 2) Reconstruction of the biliary tract history 3) severe ascites or pleural effusion 4) severe arterioportal shunt or arteriovenous shunt 5) Severe complication (Cardiac failure, Myocardial infarction, Pulmonary fibrosis, Interstitial pneumonia, Uncontrollable diabetic, Renal failure) 6) development of collateral feeding artery 7) Pregnant, nursing or possible pregnant woman 8) Heparic artery occlusion under CT angiography or angiography (Registration after qualification with CT angiography. Judging occlusion under angiography, including reservoir DAS, in case unqualified judgement with CT angiography) 9) Qualified ineligible patients being this clinical trial by responsible doctor

Design outcomes

Primary

Measure	Time frame
response rate (1 months)	—

Secondary

Measure	Time frame
adverse events, progression-free survival, overall survival	—

Countries

Japan

Contacts

Public ContactHideyuki Nishiofuku

Nara Medical University Hospital Radiology and IVR Center

hmn@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

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