Gastric cancer
Conditions
Interventions
Case series:S1/ oxaliplatin chemotherapy plus Apatinib
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients are included in the trial if they meet all of the following criteria: 1. Histologically or cytologically confirmed diagnosis of primary gastric adenocarcinoma. 2. Presence of only one of the following patterns of metastasis, which is confirmed by both computed tomography (CT) scan ,MRI , Color Doppler ultrasound ,PET-CT or Staging laparoscopy if necessary: (1) Being classified Gastric adenocarcinoma with class 1 to III and very few class IV of IV stage are divided according to the biological behavior; (2) N3; (3) extensive or bulcky lymph nodes, (4) Kukerburg tumor. 3. No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer; 4. ECOG-PS0 or 1; 5. Aged 18–70 year; 6. The Expected lifetime >= 3 month; 7. Adequate organ functions defined as indicated below: (1) Adequate bone marrow function, defined as: Hemoglobin (Hb) >= 100g/L; White blood count (WBC)>= 3.5 x 10^9/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count (PLT)>= 100 x 10^9/L. (2) Adequate liver function, defined as: Bilirubin 60 mL/min. 8. Females must not be lactating or pregnant at Screening or Baseline. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 7 days before the first dose of study drug. Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 60 days after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 60 days after study drug discontinuation); 9. Provide written informed consent; 10. Willing and able to comply with all aspects of the protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received surgery; 2. Distal metamtasis to lung ,brain,and bone; 3. History of hypertension requiring medical treatment, but systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg; 4. Significant cardiovascular impairment: history of coronary heart disease greater than New York Heart Association (NYHA) Class I, cardiac arrhythmia requiring medical treatment at Screening(Prolongation of QTc interval: Male subjects > 450 ms, Females> 470 ms), or cardiac insufficiency; 5. Gastrointestinal bleeding event; 6. Subjects having > 1+ proteinuria on urine dipstick testing will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Subjects with a urine protein >= 1 g/24 hours will be ineligible; 7. Any medical or other condition that in the opinion of the investigator would preclude the subjects participation in a clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radical resection rate; | — |
Countries
China
Contacts
Public ContactChen Lu-chuan
Fujian Cancer Hospital
Outcome results
None listed