gastric cancer
Conditions
Interventions
treatment group:limit into the grop and the ruled out
Sponsors
Yangzhong People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years men and women; 2. histopathological and / or cytology diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma, with measurable lesions (spiral CT scan is more than 10mm, X-ray, MR or ultrasound, to meet the RECIST 1.1 standard); 3. patients with advanced gastric cancer or adenocarcinoma of the esophagogastric junction; Note: (1) disease progression per line of treatment including medication time more than one or more chemotherapy for 1 cycles or longer; allow pre neoadjuvant therapy adjuvant / neoadjuvant therapy if / during or after less than 24 weeks showed tumor recurrence and metastasis, is that early adjuvant / neoadjuvant therapy is a progressive disease in the first-line chemotherapy; (2) allows early treatment is chemotherapy combined with targeted drugs (except for first-line use of apatinib.). 4. PS:0-2 ECOG 5. the main organs are normal and meet the following requirements: (1) routine inspection, to comply with (without blood transfusion within 14 days): HB = 90g/L; ANC = 1.5 * 10^9/L; PLT = 80 * 109/L (2) biochemical examination shall comply with the following criteria: BIL <1.5 normal upper limit (ULN); ALT and AST<2.5 * ULN; if liver metastasis, then ALT and AST<5 * ULN; Cr less than 1 * ULN, creatinine clearance rate was higher than 50ml/min (Cockcroft-Gault formula); 6. the expected survival time more than 3 months; 7. the doctor plans to use apatinib mesylate tablets combined with chemotherapy; 8. patients volunteered to participate in this study and signed informed consent (ICF); 9. women of childbearing age must be a pregnancy test in 7 days before entering the group (in serum or urine) were negative, and voluntary during the observation period and after the last medication for 8 weeks with the appropriate contraceptive methods; for men, for surgical sterilization, or consent during the observation period and 8 weeks after the last administration using appropriate methods of contraception.
Exclusion criteria
Exclusion criteria: 1. patients with hypertension, the antihypertensive drug treatment can not be reduced to the normal range (>140 mmHg systolic / diastolic blood pressure > 90 mmHg), suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation > 450 ms male, female, 470 MS) and heart failure; 2. have a variety of factors affecting the absorption of oral drugs (such as swallowing, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. note: with the risk of gastrointestinal bleeding of patients can not into the group, including the following: (1) with active peptic ulcer lesions, and fecal occult blood (+ +); (2) within 3 months of melena and hematemesis history; (3) for fecal occult blood (+) - and primary gastric tumor lesions without surgical, must be carried out gastroscopy, such as gastric cancer, and the doctor that may cause bleeding lesions; 4. coagulation dysfunction (INR>1.5 * ULN, APTT>1.5 * ULN), with bleeding tendency; 5. symptomatic central nervous system metastasis; 6. pregnant or lactating women; 7. other patients who are not considered suitable for inclusion in the medical profession. 8. out of line use of apatinib patients. Fall off standard: 1. failure to comply with the requirements of this program may not be effective and / or safety assessment; 2. serious violation of the plan: to participate in the study and the application of modern Chinese medicine with anti gastric cancer treatment. Termination criteria: 1. subjects withdrew informed consent and asked to quit; 2. medical imaging examination showed that the progress of the disease; 3. in the course of the study, the participants were pregnant; 4. after a dose adjustment of 1, the subjects were still unable to tolerate the toxicity; 5. the researchers considered the need to withdraw from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Countries
China
Contacts
Public ContactLu Bin
Yangzhong People's Hospital
Outcome results
None listed