Apatinib, Capecitabine, Digestive System Neoplasms, Gastrointestinal Neoplasms, Molecular Mechanisms of Pharmacological Action, Neoplasms, Stomach Diseases, Stomach Neoplasms
Conditions
Keywords
Capecitabine, Apatinib, Maintenance Treatment, Advance Gastric Cancer
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
Interventions
DRUGApatinib
Apatinib: 500mg qd po, q4w
DRUGCapecitabine
Capecitabine: 1000mg/m2 bid po, d1-14, q3w
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | six weeks | PFS is calculated from the time of randmization to disease progression or death whichever happen first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | six weeks | OS is calculated from the time of randmization to death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | six weeks | we will use EORTC QLQ-C30 to evaluate QoL. |
| Adverse Events | six weeks | we will use CTC AE4.0 to evaluate adverse events. |
Outcome results
None listed