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Study for evaluating efficacy and safety of TACE with miriplatin in the treatment of patients with hepatocellular carcinoma

Study for evaluating efficacy and safety of TACE with miriplatin in the treatment of patients with hepatocellular carcinoma - MELT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003987
Enrollment
40
Registered
2010-08-09
Start date
2010-08-01
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

Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically or clinically diagnosed HCC 2. Patients with HCC that reveals contrast-enhancement in the arterial phase of dynamic CT scan 3. Patients who do not have indication of surgical resection or local therapy including radiofrequency ablation and percutaneous ethanol injection 4. Patients who have not received previous treatment for HCC, or patients who were treated for HCC more than 3 months ago and do not reveal recurrence in the treated lesions. 5. Patients who do not have invasion to bile ducts, extrahepatic metastasis, or tumor thrombus in the portal or hepatic veins. 6. Patients with Child-Pugh class A or B. 7. Serum bilirubin level < 3 mg/dl 8. Serum creatinine level < 1.5 mg/dl 9. White blood cell count >= 3000/mm3 10. Platelet count >= 50000/mm3 11. Hemoglobin concentration >= 9.5 g/dl 12. Patients with PS score (ECOG) of 2 or less.

Exclusion criteria

Exclusion criteria: 1. Patients who have hypersensitiby to iodine or contrast media. 2. Patients who have severe thyroid or heart diseases. 3. Patients who have uncontrolled malignancies other than HCC. 4. Patients who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
Time to progression

Countries

Japan

Outcome results

None listed

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