Combination chemotherapy of hepatic arterial infusion chemotherapy with cisplatin and S-1in patients with advanced hepatocellular carcinoma: phase I trial

Combination chemotherapy of hepatic arterial infusion chemotherapy with cisplatin and S-1in patients with advanced hepatocellular carcinoma: phase I trial - Phase I trial of CDDP-HAI+S-1 in advanced HCC

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003113

Enrollment

Registered

2010-02-01

Start date

2010-02-01

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

Hepatic arterial injection of cisplatin (50-60mg/m2) conbined with S-1 The treatment is repeated every four weeks for a maximum of six courses if there is no evidence of tumor progression or unaccept

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) No indication for sorafenib 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 and fluorouracil 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
Dose limited toxicity	—

Secondary

Measure	Time frame
Response rate Progression free survival Overall survival	—

Countries

Japan

Contacts

Public ContactShunsuke Kondo

National Cancer Center Hospital Medical Oncology

shkondo@ncc.go.jp03-3542-2511

Outcome results

None listed

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