A Phase II Study of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Durvalumab in Locally Advanced or Metastatic Gallbladder Cancer
This phase II trail will evaluate the efficacy and safety of combining gemcitabine hydrochloride, cisplatin, nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation), with durvalumab in treating patients who have locally advanced or metastatic gallbladder cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab is a type of drug called a monoclonal antibody, which selectively blocks PD-L1 binding to PD-1. This anti-PD-L1 treatment works by allowing the immune system to detect your cancer and reactivates the immune response.
• Age≥18 years at time of study entry.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has histologically or cytologically confirmed unresectable locally advanced or metastatic gallbladder adenocarcinoma.
• Has at least 1 measurable disease, as defined by RECIST 1.1, at baseline.
• Has a life expectancy ≥ 3 months from proposed first dose date.
• Has received no prior anti-cancer therapy for gallbladder adenocarcinoma.
• Has adequate bone marrow, liver and renal functions measured within 14 days prior to administration of study treatment: Absolute neutrophil count≥1.5 x109/L;Platelet count≥100×109/L;Serum bilirubin≤2.5×institutional upper limit of normal (ULN). Subjects requiring biliary decompression, biliary stent, or drainage using percutaneous trans-hepatic cholangiogram are allowed (patients with a declining bilirubin status post stent placement are eligible with serum bilirubin≤2.5×ULN);Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)≤2.5×ULN;Measured creatinine clearance (CL)\>50 mL/min or calculated creatinine CL\> 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
• Women with childbearing potential should complete a pregnancy test with negative result within 28 days of study treatment and be willing to use effective contraceptive methods from screening to 90 days after the last dose of durvalumab
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm from screening to 90 days after the last dose of durvalumab.
⁃ Capable of giving written informed consent, prior to any study specific procedures,and ability to comply with the study protocol in the investigator\'s judgment.