A phase I/II study of transarterial chemoembolization with cisplatin for hepatocellular carcinoma (JIVROSG-0401)

A phase I/II study of transarterial chemoembolization with cisplatin for hepatocellular carcinoma (JIVROSG-0401) - Transarterial chemoembolization with cisplatin for hepatocellular carcinoma(JIVROSG-0401)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000049

Enrollment

Registered

2005-08-07

Start date

2005-10-01

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

Unresectable hypervascular hepatocellular carcinoma

Interventions

Patients undergo transarterial chemoembolization comprising intra-arterial infusion of cisplatin over 20-40 minutes followed by embolization with gelatin sponge particle until elimination of tumor sta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or clinically confirmed hepatocellular carcinoma. 2) No definitive extra-hepatic lesions and no indication for hepatic resection. 3) Measurable and hypervascular hepatocellular carcinoma on contrast-enhanced CT. 4) Multiple lesion in both lobes of the liver. 5) No tumor thrombus in main or 1st branch of the portal vein. 6) No influence of previous treatments. 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 8) Child-Pugh score of A or B. 9) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 10) Ages 20 years and above, under 75 years. 11) Expected survival more than 8 weeks. 12) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Prior chemotherapy with cisplatin for HCC. 2) Suspicious of extra-hepatic arterial blood supply to lesions on contrast-enhanced CT. 3) Extra-hepatic arterial blood supply to lesions on prior angiography. 4) Surgical reconstruction or endoscopic treatment involving biliary system. 5) Lymphnode metastasis or distant metastasis. 6) Other uncontrolled severe illness. 7) Active infectious disease except viral hepatitis. 8) Active other malignancies. 9) Allergic reaction to iodine contrast material, platinum containing agent, or gelatin containing agent. 10) Pregnant or nursing.

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
Response rate of liver tumor and overall response rate	—

Countries

Japan

Contacts

Public ContactYasuaki Arai

JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital

jivrosgoffice@ml.res.ncc.go.jp03-3542-2511

Outcome results

None listed

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