Two Different Treatment Methods
Conditions
Brief summary
The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.
Interventions
DRUGApatinib
Apatinib 500mg with Docetaxel 60mg/m2
Sponsors
Anhui Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients,age≥18years 2. Confirmed by Pathology or histology of Gastric cancer 3. Patients who failed first-line chemotherapy 4. The ECOG physical status score:0 to 2 5. Expected survival ≥3months 6. Patients should be voluntary to the trail and provide with signed informed consent. 7. The researchers believe patients can benefit from the study.
Exclusion criteria
1. Pregnant or lactating women 2. Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories 3. Patients with apatinib contraindications 4. Patients of doctors considered unsuitable for the trail
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival(PFS) | 1 year | From data of randomization until the date of first dccumentde progression or date of death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate (DCR) | 1year | investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor |
| Objective tumor response rate(ORR) | 1year | difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments |
| overall survival (os) | 1year | difined as the length of time from random assignment to death or to last contact |
| Quality of life score | 1 year | a questionnaire developed to assess the quality of life of cancer patients |
| adverse events | 1 year | adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events |
Countries
China
Contacts
Primary Contactyifu He, doctor
Outcome results
None listed