JPRN-jRCT2033200223已完成1 期
Phase I Study of Combination Therapy with OBP-301, Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma
Doi Toshihiko0 个研究点目标入组 4 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
OBP-301, atezolizumab, and bevacizumab were administered to 4 subjects, and none of the subjects, including 1 subject included in the initial safety evaluation, experienced adverse events that were of questionable tolerability, but the results of this study were inconclusive for initial safety evaluation.
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
- •Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology
- •Patients with cirrhosis require clinical confirmation of diagnosis based on the Clinical Practice Guidelines for Hepatocellular Carcinoma.
- •- Disease that is not amenable to curative surgical and/or locoregional therapies
- •- No prior systemic therapy (including non-approved and investigational agents) for HCC
- •- ECOG Performance Status of 0 or 1
- •- Child-Pugh class A
排除标准
- •- Fibrolamellar HCC, sarcomatoid HCC, or a mixed type of cholangiocellular carcinoma and HCC have been confirmed.
- •- The patients who have history of hepatic encephalopathy
- •- The patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
研究者
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