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。