A Study of Apatinib Versus Docetaxol Patients With Advanced Gastric Cancer

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT02409199
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Gastric Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).

Key Dates

Start date
Jun 30, 2015
Status verified
Nov 2015
Primary completion
Dec 31, 2016
Completion
Mar 31, 2017

Study Design

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

Arms

  • Experimental: apatinib
    Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
  • Active Comparator: Docetaxel
    Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measure

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

Central Contacts

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