NCT03873532

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

A Randomized, Open, Multi-center Phase IIb/III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Capecitabine in Advanced or Metastatic Biliary Tract Carcinoma (BTC) Patients

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 21-day treatment cycle).
DRUG	Capecitabine	Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID, one dose each in the morning and evening, with a total dose of 2500 mg/m2 per day) for 2 weeks followed by 1 week of drug interruption. Each course of treatment will last 3 weeks. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.

Timeline

• Start date: 2018-07-10
• Primary completion: 2021-06-01
• Completion: 2022-03-01
• First posted: 2019-03-13
• Last updated: 2020-02-13

Locations

1 site across 1 country: China