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

Fudan University

Status and phase: Unknown; Phase 3

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

Treatments: Drug: Apatinib; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03889626

Apa/Cap maintenance in GC

Details and patient eligibility

About

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 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

Enrollment: 242 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 3 patient groups

Apatinib

Experimental group

Description:

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

Treatment:

Drug: Apatinib

Capecitabine

Experimental group

Description:

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

Treatment:

Drug: Capecitabine

Observation

No Intervention group

Description:

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