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Phase 1 study of sorafenib and hepatic arterial infusion chemotherapy with Miriplatin for advanced Hepatocellular carcinoma.

Phase 1 study of sorafenib and hepatic arterial infusion chemotherapy with Miriplatin for advanced Hepatocellular carcinoma. - Phase 1 study of sorafenib and Miriplatin for advanced HCC.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008782
Enrollment
10
Registered
2012-09-01
Start date
2012-09-01
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

Administration via the catheater inserted into the hepatic artery or the implanted port of Miriplatin(65mg/m2,ia,/day) / 4 weeks. And administration sorafenib( 400~800mg /body/day ) at once.

Sponsors

Division of Gastroenterology,Kurume university School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histrogically or clinically confirmed hepatocellular carcinoma. 2.Advanced HCC no indication for liver transplantation or hepatic resection. 3.Age : 20 years old <= 4.EOCG performance status is 0 or 1. 5.Life expectancy is more than 3 months. 6.Sufficient function of main organ and conditions filled the following criteria. WBC : 2000 /mm3L <= Hb : 8.5 g/dL <= Plt : 50000 / mm3L <= S-Total Bilirubin : 2.0 mg/dL >= S-Albumin : 3.0 g/dL<= S-Creatinine : 1.5 mg/dL >= Without uncontrolled ascites and hepatic encephalopathy Ejection fraction : 45% <= PaO2 : 60mmHg <= 7.Written informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1.Previous hepatic resection or RFA within 4 weeks. 2.Patients with active double cancers. 3.Patients with concurrent infections 4.Patients with hypersensitivity to Miliplatin and contrast medium of iodine. 5.Pregnant, lacting women or women with suspected pregnancy. 6.Inappropriate patients for this study judged by physicians.

Design outcomes

Primary

MeasureTime frame
Complication

Secondary

MeasureTime frame
Response evaluation , overall survival

Countries

Japan

Contacts

Public ContactHiroaki Nagamatsu

Yame General Hospital Department of Hepatology

ymhp0389@yamehp.jp0943-23-4131

Outcome results

None listed

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