进行中(不再招募) NCT06864169

Raludotatug Deruxtecan(R-DXd)用于胃肠道癌症患者的研究(MK-5909-005)

结直肠癌胃癌胰腺癌食管癌膀胱癌/尿路上皮癌胆道癌肉瘤Phase IIIII 期IV 期

研究人员正在寻找治疗某些类型晚期胃肠道(GI)癌症的新方法。研究药物 raludotatug deruxtecan(亦称 MK-5909、R-DXd 或 DS-6000a)是一种称为抗体药物偶联物(ADC)的药物。ADC 会附著于癌细胞上的蛋白,并传递治疗以摧毁这些细胞。 本研究的主要目标是了解癌症是否对治疗产生反应(缩小或消失)。

适应症:Gastrointestinal Cancer

入组条件

纳入标准

  • 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)

排除标准

  • 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

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。