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

Phase 3

• Conditions: Capecitabine; Molecular Mechanisms of Pharmacological Action; Stomach Neoplasms; Digestive System Neoplasms; Apatinib; Stomach Diseases; Gastrointestinal Neoplasms; Neoplasms
• Interventions: Drug: Apatinib; Drug: Capecitabine

• Registration Number: NCT03889626
• Lead Sponsor: Fudan University

Brief Summary

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.

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

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-17
• Study Start: 2019-03-22
• Study First Submitted QC: 2019-03-23
• Last Update Submitted: 2019-03-23
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26
• Primary Completion: 2022-03-22
• Study Completion: 2024-03-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib	Apatinib	In this arm, patients will receive a daily oral treatment with Apatinib 500mg.
Capecitabine	Capecitabine	In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	six weeks	OS is calculated from the time of randmization to death