Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).
Conditions: Biliary Tract Neoplasms
Eligibility Criteria
Inclusion Criteria
- 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
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.