Durvalumab 或安慰剂联合 Gemcitabine/Cisplatin 用于第一线晚期胆道癌患者 (TOPAZ-1)。
适应症：Biliary Tract Neoplasms
入组条件
纳入标准
- 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
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。