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

NCT ID: NCT03889626

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2024-03-22

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib

In this arm, patients will receive a daily oral treatment with Apatinib 500mg.

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib: 500mg qd po, q4w

Capecitabine

In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Capecitabine: 1000mg/m2 bid po, d1-14, q3w

Observation

In this arm, no additional treatment will be given, and patients will be followed up at regular time

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Apatinib

Apatinib: 500mg qd po, q4w

Intervention Type: DRUG

Capecitabine

Capecitabine: 1000mg/m2 bid po, d1-14, q3w

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiaodong Zhu

Principal Investigator and Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Apa/Cap maintenance in GC

Identifier Type: -

Identifier Source: org_study_id