Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer

Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study ID
NCT02537171
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.

Study Details

The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction.

Key Dates

Start date
Jul 31, 2015
Status verified
Aug 2015
Primary completion
Aug 31, 2016
Completion
Oct 31, 2016

Study Design

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

Arms

  • Active Comparator: Apatinib 750mg group
    Apatinib mesylate tablets(ATAN) is taken 750mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.The dose of the study drug may be modified following the occurence of a clinically significant adverse event(AE).
  • Active Comparator: Apatinib 500mg group
    Apatinib Mesylate Tablets(ATAN) is taken 500mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.Treatment will be discontinued if the subject is unable to tolerate a daily dose of 500mg.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 1 year ]

Central Contacts

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