Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer
- Sponsor
- Huazhong University of Science and Technology
- Study ID
- NCT03598348
- Phase
- PHASE3
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Apatinib+Capecitabine — DRUGCapecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
- Apatinib — DRUGApatinib 250mg po Qd
Study Details
This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer
Key Dates
- Start date
- Jan 16, 2018
- Status verified
- Jul 2018
- Primary completion
- Jan 16, 2020
- Completion
- Oct 16, 2020
Study Design
- Enrollment
- 288 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Maintenance Treatment Group AMaintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
- No Intervention: Observation GroupObservation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
- Experimental: Maintenance Treatment Group BMaintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer
Primary Outcome Measure
PFS [ Time Frame: 36 months ]
Central Contacts
- Xianglin Yuan, PhD,MD8627-83663406
- Ping Peng, PhD,MD8627-83663407
Related Studies
- Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer PatientsRecruiting · Vanderbilt University Medical Center · Nashville, Tennessee
- The Gastric Cancer Foundation: A Gastric Cancer RegistryRecruiting · Stanford University · Stanford, California
- Integrated Cancer Repository for Cancer ResearchRecruiting · University of Nebraska · Greenwood Village, Colorado
- Feasibility of the LUM Imaging System for Detection of Gastrointestinal CancersPHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts