Apatinib Combined With Capecitabine Compared With Apatinib Treat Advanced Hepatocellular Carcinoma

Sponsor
First Affiliated Hospital of Guangxi Medical University
Study ID
NCT03114085
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;
  • Apatinib — DRUG
    Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle

Study Details

It is an open,randomized,controlled study, and the purpose of this study is to observe and evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma.

Key Dates

Start date
May 20, 2017
Status verified
May 2017
Primary completion
Mar 20, 2019
Completion
May 20, 2019

Study Design

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

Arms

  • Experimental: Apatinib Combined with Capecitabine
    Apatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group; Capecitabine,1000mg/m2,twice a day (at intervals of 12 hours,equivalent to a total daily dose of 2000 mg / m2),orally,sustained 14 days, off for 7 days, every 21 days for a cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group.
  • Active Comparator: Apatinib
    Apatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group;

Primary Outcome Measure

time to progression [ Time Frame: through study completion, an average of 2 years ]

Central Contacts

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