癌研連線CancerLink
进行中（不再招募） NCT05043090

Savolitinib 联合 durvalumab 对比 sunitinib 及 durvalumab 单药治疗用于 MET 驱动、不可切除及局部晚期或转移性 PRCC

肾癌Phase IIIIII 期IV 期MET

一项临床试验，比较 savolitinib 联合 durvalumab 与 sunitinib 用于 MET 驱动（肝细胞生长因子受体）、不可切除及局部晚期或转移性 PRCC（乳头状肾细胞癌）的疗效。

适应症：Papillary Renal Cell Carcinoma

入组条件

纳入标准

  • Histologically confirmed unresectable and locally advanced or metastatic PRCC
  • PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay
  • No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
  • Karnofsky Score \>70
  • At least one lesion, not previously irradiated, that can be accurately measured at baseline
  • Adequate organ and bone marrow function
  • Life expectancy ≥12weeks at Day 1

排除标准

  • History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs
  • Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
  • Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
  • Active infection including HIV, TB, HBV and HCV
  • Active or prior documented autoimmune or inflammatory disorders
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。