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

NCT03873532 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

  • Biliary Tract Cancer

Interventions

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.

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Rongjun Liu · Hutchison Medipharma Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2021-06-30
Completion
2022-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03873532 on ClinicalTrials.gov