A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients

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Description

This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects are randomly assigned t...

This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs. Capecitabine as a second-line therapy in patients with unresectable or metastatic biliary tract cancer (BTC). About 298 subjects are randomly assigned to two study treatment groups in the ratio of 1:1 by IWRS. Active group: 300 mg of surufatinib is given by oral administration once a day (QD) every 3 weeks; Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID) for 2 weeks, followed by 1 week rest period (equivalent to 2500 mg/m2 total daily dose). Patients are randomized with the following stratification factors: Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1); Years from the first diagnosis of BTC to the randomization date (? 1 year or > 1 year); The primary site of the tumor (intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer). All patients will be treated based on the arm to which they have been randomized. Treatment on study will continue until disease progression, death, intolerable toxicity or other criteria for discontinuation from study treatment. The tumor assessments are performed with imaging every 6 weeks (+3 days) until progressive disease (RECIST v1.1) or death on the study treatment period, and the treatment and survival of the patients after progressive disease are recorded. Safety indicators include adverse events, laboratory tests, vital signs, and changes in electrocardiograms and echocardiograms.

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