進行中(不再收案) NCT03875235

Durvalumab 或安慰劑聯合 Gemcitabine/Cisplatin 用於第一線晚期膽道癌患者 (TOPAZ-1)

膀胱癌/泌尿道上皮癌膽道癌Phase IIIIII 期IV 期

Durvalumab 或安慰劑聯合 Gemcitabine/Cisplatin 用於第一線晚期膽道癌患者 (TOPAZ-1)。

適應症:Biliary Tract Neoplasms

收案條件

納入條件

  • Inclusion
  • Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  • Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
  • Patient with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
  • WHO/ECOG PS of 0 or 1
  • Exclusion
  • History of another primary malignancy
  • Brain metastases or spinal cord compression
  • Uncontrolled intercurrent illness
  • Major surgical procedure within 28 days prior to the first dose of IP.
  • Prior locoregional therapy such as radioembolization

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。