The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Diagnosed with metastatic gastric cancer patients (including the esophagogastric junction adenocarcinoma), DS(docetaxel and Tegafur)and Mesylate apatinib 6 cycles, the specific amount of usage: DS Docetaxel 75mg/m2 D1 IV.drop 1H(one hour), Tegafur(BSA\<1.25 40mg Po bid(twice a day), BSA \>=1.25-\<1.5 50mg Po bid, BSA \>=1.5 60mg Po bid, Q21d(21 days a cycle)); Mesylate Apatinib 500mg Po QD(once a day)) continuous use, until disease deterioration.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGprogress-free survival time
During the treatment, the investigators will arrange patients to underwent CT and MRI examination on time, evaluating the size and the number of the tumor, to determine whether the disease progress than before; and the time from the start of treatment to the progression is progress-free survival time.
Time frame: 30 months
Overall survival Time
During and after treatment, all patients were followed up regularly ,the patients will be arranged to evaluate the Performance status score or Karnofsky Performance Score to assess the patient's health and disease controling, until the patient died; the time from the beginning of treatment to death is overall survival time.
Time frame: 30 months
Overall remission Rate
During the treatment, the investigators will regularly arrange patients to underwent CT, MRI ,Tumor marker examination and so on, evaluating the size and the number of the tumor, utilizing Response Evaluation Criteria in Solid Tumors to assess whether the disease progress than previous; and the percentage of patients with complete remission and partial remission of the disease is Overall remission Rate.
Time frame: during 6 cycles of chemotherapy (each cycle is 28 days)
adverse events
During and after treatment, the investigators will on the basis of The clinical application expert consensus of Mesylate Apatinib to cure gastric cancer and The evaluation criteria of adverse drug reaction to assess patients who accepted treatment whether has adverse events.
Time frame: up to 28 weeks
Quality of life
During and after treatment, the investigators will on the basis of The Lancashire Quality of Life Profile to assess the patients' life quality regularly.
Time frame: 30 months
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disease control rate
During the treatment, the investigators will regularly arrange patients to underwent CT, MRI ,Tumor marker examination and so on, to assess the size and the number of the tumor, utilizing Response Evaluation Criteria in Solid Tumors to assess whether the disease progress than previous; and the percentage of patients with disease control is disease control rate.
Time frame: 30 months