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Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma

Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma - Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013204
Enrollment
56
Registered
2014-05-30
Start date
2014-07-15
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

hepatocellular carcinoma

Interventions

TACE with miriplatin TACE with DC bead

Sponsors

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Clinically diagnosed as hepatocellular carcinoma patient. 2)Unresectable hepatocellular carcinoma. 3)20 years of age or older. 4)ECOG performance status 0 or 1. 5)Having measurable lesion in the liver. 6)TMN stage 2 or 3 7)Having indication for TACE. 8)Total birilubin<3.0mg/dl, AST and ALT equal to or less than five times the upper limit. 9)Elapsed 4 weeks or more after previous treatment. 10)Obtained written consent from the patient. 11)Child-Pugh score A or B. 12)Possible to perform the study procedure. 13)Obtained written consent from the patient before study.

Exclusion criteria

Exclusion criteria: 1)Having metastasis. 2)Having vascular invasion. 3)Having vascular anormality or AP shunt. 4)Having previous treatment with miriplatin or DC bead. 5)Having previous treatment with sorafenib. 6)Having severe ascites or pleural effusion. 7)Considered as HCC refractory for TACE. 8)Having allergy of contrast agent. 9)Having severe renal failure. 10)Having severe cardiac disease. 11)Having other cancer. 12)Having hemorrhagic varix. 13)Having severe mental disorder. 14)Having severe drug allergy. 15)Having possibility of pregnant or nursing. 16)Deemed inappropriate to perform the study by the physician.

Design outcomes

Primary

MeasureTime frame
Anti-tumor response

Secondary

MeasureTime frame
Progression free survival

Countries

Japan

Contacts

Public ContactYoji Ishizu

Nagoya University Graduate School of Medicine, Aichi, Japan Department of Gastroenterology and Hepatology

y-ishizu@med.nagoya-u.ac.jp052-744-2169

Outcome results

None listed

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