進行中(不再收案) NCT06109779

rilvegostomig 加化療作為膽道癌切除術後輔助治療(ARTEMIDE-Biliary01)

膀胱癌/泌尿道上皮癌膽道癌神經內分泌腫瘤Phase IIIIII 期IV 期

一項全球研究,評估 rilvegostomig 對比安慰劑聯合研究者選擇的化療,用於接受根治性意圖手術切除後膽道癌(BTC)參與者的療效及耐受性。

適應症:Biliary Tract Cancer

收案條件

納入條件

  • Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
  • Provision of a tumor sample collected at surgical resection.
  • Randomization within 12 weeks after resection with adequate healing and removal of drains.
  • Confirmed to be disease-free by imaging within 28 days prior to randomization.
  • Eastern Cooperative Oncology Group performance status of 0 or 1

排除條件

  • Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
  • Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
  • Any anti-cancer therapy for BTC prior to surgery
  • Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
  • Current or prior use of immunosuppressive medication within 14 days before the first dose
  • Thromboembolic event within 3 months
  • Active HBV or HCV infection unless treated.

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。