進行中(不再收案) NCT05043090

Savolitinib 聯合 durvalumab 對比 sunitinib 及 durvalumab 單藥治療用於 MET 驅動、不可切除及局部晚期或轉移性 PRCC

腎癌Phase IIIIII 期IV 期MET

一項臨床試驗,比較 savolitinib 聯合 durvalumab 與 sunitinib 用於 MET 驅動(肝細胞生長因子受體)、不可切除及局部晚期或轉移性 PRCC(乳頭狀腎細胞癌)的療效。

適應症:Papillary Renal Cell Carcinoma

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。