A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis

A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis - Hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000488

Enrollment

Registered

2006-09-12

Start date

2005-01-01

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

Advanced hepatocellular carcinoma with portal vein tumor thrombosis

Interventions

A dose of 65 mg/m2 of cisplatin is administered for 20 to 40 minutes from hepatic artery. Treatment is repeated every 4 to 6 weeks for a maximum of six courses, if there is no evidence of tumor progre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Advanced hepatocellular carcinoma with confirmation of histological examination or typical computed tomographic, angiographic findings and elevated serum alpha-fetoprotein levels 2) No indication for surgical resection 3) Tumor thrombosis in the main and/or first portal vein 4) Aged 20 years or over 5) An Eastern Cooperative Oncology Group performance status of 0-2 6) Measurable disease 7) Sufficient organ function: WBC>=3,000 /mm3, Hb>=9.0 g/dL, PLT>=50,000 /mm3, Child-Pugh grade A or B, T-Bil<=2.0 mg/dL, AST<=150 U/L, ALT<=150 U/L, Creatinine<=1.1 mg/dL 8) Interval of 4 weeks or over between last treatment and present therapy, and no influence of previous treatments 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Prior chemotherapy with cisplatin for hepatocellular carcinoma 2) Prior radiotherapy, transcatheter arterial chemoembolization, and hepatic arterial chemotherapy for portal vein tumor thrombosis of hepatocellular carcinoma 3) Refractory pleural effusion or ascites 4) Distant metastases 5) Allergic reaction to iodine contrast material 6) Severe renal disease 7) Severe heart disease 8) Active infection excluding hepatitis B or C viral infection 9) Active concomitant malignancy 10) Severe mental disorder 11) Severe allergic reaction to drug 12) Pregnant and lactating females; females of childbearing age unless using effective contraception

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
adverse events, survival, and progression free survival	—

Countries

Japan

Contacts

Public ContactMasafumi Ikeda, MD.

CDDP HAI Coordinating Office Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital

masikeda@ncc.go.jp03-3542-2511

Outcome results

None listed

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