not operable, recurrent or metastatic advanced gastric or gastric esophageal junction adenocarcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years; 2. ECOG PS 0-2; 3. Advanced gastric cancer or gastric esophageal junction adenocarcinoma confirmed by pathological histology and/or cytology(Unable to surgery III-IV period);(patients who recurred of clinical treatment 5 years later.); 4. Have not received chemotherapy or other targeted therapy in the past; 5. Estimated survival time=3 mouths; 6. If the main organs function normally, and meet the following standards: (1) the standard of blood routine examination should meet :(no blood transfusion and blood products within 14 days) WBC > 4.0 x 10^9/L; ANC =1.5 x 10^9/L; PLT = 80 x 10^9/L; HGB =80 g/L; (2) biochemical examination shall meet the following standards: TBIL 50 ml/min (Cockcroft - Gault); 7. Surgery was performed more than 4 weeks ago and the wound was completely healed; 8. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib. For male, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib; 9. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Accompanied by serious heart, liver and kidney diseases;Neurological and mental diseases;severe infection; 2. Clear tendency to gastrointestinal bleeding such as:bleeding ulcers,fecal occult blood (++);A history of black stool and hematemesis within 2 months; Abnormal blood coagulation function (INR>1.5 x ULN, APTT>1.5 x ULN); 3. Hypertension and failure to be reduced to normal range by antihypertensive drugs( Systolic pressure>140mmHg, Diastolic pressure >90mmHg); Unstable angina pectoris; Newly diagnosed with angina pectoris within 3 months before screening or with myocardial infarction within 6 months before screening; Cardiac arrhythmia (including QTcF: 450 ms for men and 470 ms for women) requires long-term use of anti-arrhythmia drugs and grade II cardiac insufficiency according to the New York heart association; 4. Have significant impacts on oral absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 5. Women who are pregnant or lactating; Persons with fertility who are unwilling or unable to take effective contraceptive measures; 6. Participated in other clinical trials of anti-tumor drugs within 4 weeks; 7. Have received any radiotherapy, chemotherapy and targeted treatment before; 8. The researchers consider those who were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Surivical; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Surivival;Disease Control Rate;Objective Remission Rate;QoL; | — |
Countries
China
Contacts
Gansu Province Cancer Hospital