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临床试验/JPRN-UMIN000000774
JPRN-UMIN000000774已完成2 期

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 个研究点目标入组 120 人开始时间: 2007年7月26日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 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.

研究者

发起方
Graduate School of Medicine, Osaka University Department of Surgery

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