The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction.
The study is to investigate the efficacy of Apatinib as maintenance therapy after first fine treatment in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction through progression-free survival(PFS). Apatinib will be given to patients who have received first-line chemotherapy with an efficacy assessment of stable disease(SD), complete response(CR), or partial response(PR) after 4 cycles. Patients were randomly assigned to 750mg group or 500mg group continually until disease progression or intolerable toxicity or patients withdrawal of consent, and the sample size is 40 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.
307 Hospital of PLA
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival (PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Time frame: 1 year
disease control rate(DCR)
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
Time frame: 1year
Objective tumor response rate(ORR)
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
Time frame: 1year
overall survival(OS)
OS is defined as the length of time from random assignment to death or to last contact.
Time frame: 3year
Quality of life score (QoL)
QoL is a questionnaire developed to assess the quality of life of cancer patients.
Time frame: 1year
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: 1year
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