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Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and Cisplatin for advanced hepatocellular carcinoma.

Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and Cisplatin for advanced hepatocellular carcinoma. - Phase II study of weekly fractionated hepatic arterial infusion of Sorafenib and CDDP for advanced

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008571
Enrollment
33
Registered
2012-07-31
Start date
2012-07-01
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

This study aimed to evaluate the efficacy of Sorafenib and hepatic arterial infusion with Cisplatin for advanced hepatocellular carcinoma.

Sponsors

Kansai Medical University Hirakata Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with HCC 2.Above vp3 3.Child-Pugh A or B 4.ASA PS 0-1 5.WBC>3000/ul, Neutro>1500/ul, Hb>10.0g/dl, Platelet>75000/ul, T-Bil below 1.5 times higher than normal range, AST/ALT below 5 times higher than normal range, Creatinine below 1.5 times higher than normal range. 6.Beyond surgical indication 7.Patients that agree this study on document of informed concent

Exclusion criteria

Exclusion criteria: 1.Presence of metastasis 2.Presence of hepatic encephalopathy 3.Patients with active bacterial infection 4.Patients having blood vessel abnormality that difficult to insert hepatic arterial infusion port 5.Patients having severe disease 6.Patients losing of control over bowel movements 7.Patients with double cance 8.During pregnancy or breast-feeding woman 9.Contraindication of sorafenib or cisplatin

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Progression free survival, Overall survival, Adverse event rate

Countries

Japan

Contacts

Public ContactMorihiko Ishizaki

Kansai Medical University Hirakata Hospital Department of surgery

ishizakm@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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