JPRN-UMIN000002590已完成1 期
A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma - A phase 1 study of TS-1 and sorafenib combination therapy in patients with advanced hepatocellular carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Previous therapy for hepatocellular carcinoma within 30days before study entry 2)Major surgery within 30 days before study entry or surgery within 15 days before study entry 3)Portal vein tumor thrombs in the main trunk 4)Uncontrollable hypertension 5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics 6)Hepatoencepharopathy. Brain lesions with clinical symptoms 7)Central nerve system tumor(including brain metastasis) 8)Bone metastasis with clinical symptoms 9)Active infection(except HBV and HCV infection) 10)Evidence of serious gastrointestinal bleeding within 30days before study entry 11)Gastro-esophazeal varices requiring preventive treatment 12)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment 13)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence) 14)Severe hypersensitivity of TS-1 or sorafenib 15)Severe complication 16)Any patients judged by the investigator to be unfit to participate in the study
研究者
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