CTIS2023-505816-39-00招募中1 期
A Randomized, Open-Label, Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma - BO43936
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 217
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
- •International Metastatic Renal Cell Carcinoma Database Consortium IMDC risk intermediate (score of 1 or 2), or poor (score of 3 to 6), Measurable disease, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Adequate hematologic and end-organ function (within 14 days prior to study treatment), Histologically confirmed clear-cell renal cell carcinoma renal cell carcinoma (ccRCC) with or without sarcomatoid features; non-clear-cell renal cell carcinoma (nccRCC) subtypes (papillary, chromophobe, and unclassified) are not allowed., Negative hepatitis B surface antigen (HBsAg) test and hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening, Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening
排除标准
- •Prior treatment for localized and/or metastatic RCC with systemic RCC directed therapy, Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer, Symptomatic, untreated, or actively progressing CNS metastases, History of leptomeningeal disease, Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment., Moderate to severe hepatic impairment (Child-Pugh B or C)
研究者
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