進行中(不再收案) NCT06864169

Raludotatug Deruxtecan(R-DXd)用於胃腸道癌症患者的研究(MK-5909-005)

大腸直腸癌胃癌胰臟癌食道癌膀胱癌/泌尿道上皮癌膽道癌肉瘤Phase IIIII 期IV 期

研究人員正在尋找治療某些類型晚期胃腸道(GI)癌症的新方法。研究藥物 raludotatug deruxtecan(亦稱 MK-5909、R-DXd 或 DS-6000a)是一種稱為抗體藥物偶聯物(ADC)的藥物。ADC 會附著於癌細胞上的蛋白,並傳遞治療以摧毀這些細胞。 本研究的主要目標是了解癌症是否對治療產生反應(縮小或消失)。

適應症:Gastrointestinal Cancer

收案條件

納入條件

  • Has one of the following cancers:
  • Unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)
  • Unresectable or metastatic adenocarcinoma of the biliary tract \[intra- or extrahepatic holangiocarcinoma (CCA) or gallbladder cancer (GBC)\]
  • Unresectable or metastatic colorectal adenocarcinoma
  • Unresectable or metastatic gastric adenocarcinoma
  • Gastroesophageal junction adenocarcinoma (GEJAC)
  • Esophageal adenocarcinoma (EAC)
  • Has received prior therapy for the cancer
  • Has a life expectancy of at least 3 months
  • If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)

排除條件

  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Has uncontrolled or significant cardiovascular disease
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Has not adequately recovered from major surgery or has ongoing surgical complications
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

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。