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

Graduate School of Medicine, Osaka University Department of Surgery0 sites120 target enrollmentJuly 26, 2007

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Advanced hepatocellular carcinoma with extrahepatic metastasis
Sponsor: Graduate School of Medicine, Osaka University Department of Surgery
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

July 26, 2007

End Date

May 1, 2011

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Graduate School of Medicine, Osaka University Department of Surgery

•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.