A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

Sponsor
First Affiliated Hospital of Guangxi Medical University
Study ID
NCT03609489
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine, 1000mg/m2, oral administration, twice daily (once in the morning and once in the evening with an interval of 12 hours, equivalent to a total daily dose of 2000 mg/m2), continuous medication for 14 days and off for 7 days. Every 21 days is a cycle, and there shall be a total of 8 cycles. If the subject is still unable to tolerate toxicity after experiencing two dose adjustments, he/she should be moved out of the group.
  • Apatinib — DRUG
    Apatinib, 500 mg, administered orally (after breakfast) once daily from day 1 to day 21 (including day 21) with continuous administration. Every 21 days serve as a cycle. If after 2 dose adjustments, the subject is still unable to tolerate toxicity, he/she should be moved out of the group.

Study Details

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.

Key Dates

Start date
Sep 10, 2018
Status verified
Aug 2018
Primary completion
Jun 10, 2021
Completion
Dec 25, 2021

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Group
    Apatinib combined with Capetabine
  • Active Comparator: Control Group
    Capecitabine

Primary Outcome Measure

Progression-free survival [ Time Frame: 12 months ]

Central Contacts