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

  • STATUS
    Recruiting
  • participants needed
    298
  • sponsor
    Hutchison Medipharma Limited
Updated on 29 June 2022
carcinoma
combination chemotherapy
progressive disease
capecitabine
gemcitabine
adjuvant chemotherapy
cholangiocarcinoma
metastatic biliary tract carcinoma
gallbladder cancer
extrahepatic cholangiocarcinoma
biliary tract carcinoma
intrahepatic bile duct carcinoma
biliary tract cancer
surufatinib

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 surufatinibonce 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.

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 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.

Details
Condition Biliary Tract Cancer
Treatment Capecitabine, Surufatinib
Clinical Study IdentifierNCT03873532
SponsorHutchison Medipharma Limited
Last Modified on29 June 2022

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note