A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
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 Interactive Web
Response System (IWRS).
- Active group: 300 mg of surufatinib，once a day for 3 weeks as a cycle;
- Control group: In each 3-week cycle, Capecitabine is given at 1250 mg/m2 by oral
administration twice a day for 2 weeks, followed by 1 week rest period (equivalent to
2500 mg/m2 total daily dose).
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.