A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Criterios de inclusión

• 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