Clinical trial NCT03889626: The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer
Official title: A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Diseases
Digestive System Neoplasms
Capecitabine
Apatinib
Neoplasms
Molecular Mechanisms of Pharmacological Action
Keywords: Capecitabine
Apatinib
Maintenance Treatment
Advance Gastric Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: six weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: six weeks
Other outcomes:
measure: Quality of Life (QoL)
timeFrame: six weeks
measure: Adverse Events
timeFrame: six weeks
Locations:
Study officials:
References: