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Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma

Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma - Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004790
Enrollment
200
Registered
2010-12-24
Start date
2010-07-01
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

Hepatocellular carcinoma

Interventions

Sponsors

Kitasato University Scool of Medicine, Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with HCC that are histologically or clinically confirmed, unsuitable for resection or locoregional therapy. 2) TNM stage 2 or 3. 3) Patients with HCC that show arterial phase enhancement. 4) Child-Pugh class A or B. 5) History of treatment for HCC within previous 3 months. 6) A life expectancy of 3 months or more. 7) Performance status score (ECOG) of 2 or less. 8) Patients who fulfill of the inclusion criteria below. 1. WBC >=2000/mm3 2. PLT >=50000/mm3 3. Hb >=8.0g/d/dl 4.T.Bil <=3.0mg/dl 5. PT >=40% 6. AST, ALT <=5 x the upper limit of the normal range. 7. Cr <=the upper limit of the normal range. 9) Patients who were provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Vascular invasion or bile duct invasion. 2) Extrahepatic metastasis. 3) Major arterioportal shunt in the liver. 4) Combination with locoregional therapy. 5) Hepatic encephalopathy or refractory ascites. 6) Adjuvant therapy with IFN, Vit A or anti cancer drug. 7) Patients who have medical history of hypersensitivity of iodine or contrast media. 8) Patients who have severe thyroid disease. 9) Patients who are pregnant, lactating or are suspected to be pregnant. 10) Patients who are concluded to be inappropriate to participate in this study by their physicians.

Design outcomes

Primary

MeasureTime frame
Time to progression

Secondary

MeasureTime frame
Response rate Safety Overall survival

Countries

Japan

Contacts

Public ContactYusuke Okuwaki

Kitasato University East Hospital Department of Gastroenterology

okuyu@kitasato-u.ac.jp042-748-9111

Outcome results

None listed

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