A Prospective Observational Study of Molecular Classification and Circulating Tumor DNA Dynamic Monitoring to Explore Related Factors That Predict the Efficacy of Single Targeted Therapy or Combined With Immunotherapy for Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Next-Generation Sequencing and whole transcriptome RNA sequencing were used to detect genomic variation and expression in tissues or blood, respectively. The treatment outcome of single targeted therapy or combined with immunotherapy was observed and followed up. Through this study, we intend to achieve RNA molecular classification of Chinese mRCC patients and to evaluate the correlation between ctDNA level, RNA molecular classification and treatment outcome, provide reference for metastatic RCC precise diagnosis and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with renal cell carcinoma confirmed by pathology, including clear renal cell carcinoma and type I papillary renal cell carcinoma, type II papillary renal cell carcinoma, chromophobe renal cell carcinoma and renal cell carcinoma with sarcomatoid differentiation, etc
- •Have distant metastasis
- •metastatic RCC
- •Eastern Cooperative Oncology Group 0 to 1
- •No obvious abnormality was found in blood routine examination, coagulation and liver and kidney function
排除标准
- •• Previously received systematic treatment
- •Failure to obtain baseline tumor tissue / blood samples
- •A history of infection with human immunodeficiency virus, or suffer from other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation, or have a history of organ transplantation
- •A history of allergy to disease treatment drugs
- •During lactation or pregnancy
研究组 & 干预措施
Single targeted therapy
sunitinib or pazopanib
干预措施: sunitinib or pazopanib (Drug)
targeted therapy combined with immunotherapy
Programmed death-ligand 1 Inhibitor combined with axitinib
干预措施: PD-1 inhibitor combined with axitinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: From drug taken until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
次要结局
- Objective Response Rate(From drug taken until the date of first documented progression, assessed up to 20 months)