JPRN-jRCT2080223794已完成1 期
A Phase 1b Trial of Lenvatinib Plus Nivolumab in Subjects With Hepatocellular
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Participants must have confirmed diagnosis of hepatocellular carcinoma (HCC) with any of the following criteria:
- •- Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
- •- Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection
- •(2)Part 1: HCC for which no other appropriate therapy is available; Part 2: No prior systemic therapy for advanced/unresectable HCC
- •(3)Participants categorized to stage B (not applicable for transarterial chemoembolization), or stage C based on Barcelona Clinic Liver Cancer staging system
- •(4)Child-Pugh score A
- •(5) Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 to 1
- •(6) Age >=20 years at the time of informed consent
排除标准
- •(1)Active co-infection with hepatitis B and hepatitis C
- •(2)Participants with any active, known, or suspected autoimmune disease
- •(3)Participants being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study
- •(4)Females who are breastfeeding or pregnant
研究者
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