CTIS2022-502317-29-00招募中1 期
A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary) - D7987C00001
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 260
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age =18 years at the time of signing the ICF., Provision of a signed and dated written ICF., Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology., Adequate organ and bone marrow function., At least 1 measurable not previously irradiated lesion per RECIST 1.1, Life expectancy of at least 12 weeks at the time of screening., Willing and able to provide an adequate tumor sample.
排除标准
- •HCC only: History of allogeneic organ transplantation or in the waiting-list of allogeneic organ transplantation., Active or prior documented autoimmune or inflammatory disorders., Uncontrolled intercurrent illness., History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency., Active infection, brain metastases or spinal cord compression., HCC only: History of hepatic encephalopathy within 12 months prior to treatment allocation., Previous treatment in the present study., Participants co-infected with HBV and hepatitis D virus (HDV), BTC only: History of allogeneic organ transplantation.
研究者
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