招募中 NCT07227402

Belzutifan和Zanzalintinib在輔助治療後復發性腎癌患者中的臨床研究( MK-6482-033 )

腎癌肉瘤Phase IIIIII 期IV 期

研究人員正在尋找更多方法來治療復發的晚期腎細胞癌( RCC )。 研究人員希望了解與cabozantinib相比, Belzutifan ( MK-6482 )和zanzalintinib治療後復發性晚期腎細胞癌( RCC )是否有反應(變小或消失)。 本研究的目的是了解: 服用Belzutifan和Zanzalintinib的人總體壽命更長,而且癌症不會比服用Belzutifan和Zanzalintinib的人更糟。

適應症:Renal Cell Carcinoma

收案條件

納入條件

  • Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
  • Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy
  • Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy

排除條件

  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
  • Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
  • Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
  • Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
  • Has current pneumonitis/interstitial lung disease
  • Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
  • Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
  • Has a serious active nonhealing wound/ulcer/bone fracture
  • Has a requirement for hemodialysis or peritoneal dialysis
  • Has history of human immunodeficiency virus infection
  • Has hepatitis B or hepatitis C virus
  • Has pharmacologically uncompensated, symptomatic hypothyroidism
  • Received a live or live-attenuated vaccine within 30 days before 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。