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

• Status: Not yet recruiting
• Trial end date: 2024-03-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Apatinib; Capecitabine

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