The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

Sponsor
Fudan University
Study ID
NCT03889626
Phase
PHASE3
Status
Unknown

Conditions

  • Apatinib
  • Capecitabine
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Molecular Mechanisms of Pharmacological Action
  • Neoplasms
  • Stomach Diseases
  • Stomach Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib: 500mg qd po, q4w
  • Capecitabine — DRUG
    Capecitabine: 1000mg/m2 bid po, d1-14, q3w

Study Details

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Key Dates

Start date
Mar 22, 2019
Status verified
Mar 2019
Primary completion
Mar 22, 2022
Completion
Mar 22, 2024

Study Design

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

Arms

  • Experimental: Apatinib
    In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
  • Experimental: Capecitabine
    In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.
  • No Intervention: Observation
    In this arm, no additional treatment will be given, and patients will be followed up at regular time

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: six weeks ]

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