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

Overview

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.

Full Title of Study: “A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 22, 2022

Detailed Description

Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Progression Free Survival (PFS)
    • Time Frame: six weeks
    • PFS is calculated from the time of randmization to disease progression or death whichever happen first

Secondary Measures

  • Overall Survival (OS)
    • Time Frame: six weeks
    • OS is calculated from the time of randmization to death

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma – ECOG PS 0-2 – At least one measurable or evaluable lesion in the first-line chemotherapy – The fist line treatment should be 5-FU based regimen (e.g. ECF/EOF/EOX/FOLFOX/XELOX/XP) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-PD – The time from the last cycle treatment to the enrollment cannot exceed 6 weeks – Adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/L, neutrophil ≥1.5×109/L, hemoglobin ≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the ULN) Exclusion Criteria:

  • Received 2 or more regimens for palliative chemotherapy – Pregnant or lactating women – Concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix – Uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction – Clinically significant active bleeding, OB 2+ or higher – Patients with locally advanced gastric cancer who are scheduled to receive radiotherapy – Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia – Uncontrolled significant comorbid conditions

Gender Eligibility: All

no younger than 18 year-old

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaodong Zhu, Principal Investigator and Clinical Professor – Fudan University

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