Multicenter Phase II Randomized Controlled Trial of S-1 and Interferon-alpha Combined Chemotherapy or S-1 Alone in Advanced Hepatocellular Carcinoma with Extrahepatic Metastasis

Multicenter Phase II Randomized Controlled Trial of S-1 and Interferon-alpha Combined Chemotherapy or S-1 Alone in Advanced Hepatocellular Carcinoma with Extrahepatic Metastasis - Randomized Phase II Trial of S-1 and Interferon-alpha or S-1 Alone in Metastatic Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000774

Enrollment

120

Registered

2007-07-26

Start date

2007-06-01

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 extrahepatic metastasis

Interventions

S-1 80mg/m2 per os day1~28 and no administration day29~42 for 1 course Treatment repeats every 42 days for 2-6 courses S-1 80mg/m2 per os day1~28 IFN-alpha 5 million units sc 3 times a week f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven or clinically diagnosed hepatocellular carcinoma in primary lesion. 2) At least one measurable extrahepatic lesion. 3) Well controlled intrahepatic lesion, if any. 4) No prior treatment for extrahepatic lesion. 5) Child-Pugh score A or B 6) ECOG performance status of 0-1 7) Ability to take medications orally. 8) Age 20-80 9) Adequate organ and marrow function listed below. 1.White blood cell(WBC): 3,000<=WBC<12,000/uL 2.Absolute neutrophil count(Neu): Neu >=1,500/uL 3.Hemoglobin(Hb): Hb>=9.0g/dL 4.Platelet count(Plt): Plt>=70,000/uL 5.Total Bilirubin(T-Bil): T-Bil<=1.5mg/dL 6.AST: AST<=150IU/L 7.ALT: ALT<=150IU/L 8.Serum creatinine(Cr): Cr<=1.2mg/dL 9.Serum albumin(Alb): Alb>=2.8g/dL 10) Life expectancy at least 6 months. 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Histologically diagnosed combined type of hepatocellular carcinoma and cholangiocellular carcinoma in primary lesion. 2) Radiographic evidence of portal vein tumor thrombus in major branch or first branches (Vp3 or Vp4 in the liver cancer study group of Japan.) 3) Radiographic evidence of vascular invasion in hepatic vein or hepatic artery or bile duct. 4) Known bone metastasis. 5) Known brain metastasis. 6) Hepatic encephalopathy. 7) Active infectious disease. 8) Other severe concomitant disease or medical conditions. 9) Chronic diarrhea or any disorder that will limit adequate absorption of S-1. 10) Other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, from which the patient has been disease-free for 5 years. 11) Pregnant or lactating women. 12) Concurrent systemic chemotherapy. 13) Any contraindication for S-1 medication. 14) Any contraindication for interferon-alpha administration. 15) Inappropriate patients for entry on this trial in the judgement of the investigator.

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
Clinical Response (anti-tumor effect) Progression Free Survival Incidence of Adverse Event	—

Countries

Japan

Contacts

Public ContactHiroaki Nagano

Graduate School of Medicine, Osaka University Department of Surgery

06-6879-3251

Outcome results

None listed

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