Advanced gastric cancer or adenocarcinoma of the esophageal junction of the stomach
Conditions
Interventions
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
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; 4. Have not received chemotherapy or other targeted therapy in the past. Note: the treatment used in the new auxiliary treatment stage is not included in the treatment plan.If a recurrence occurs within 6 months after the end of adjuvant therapy, the adjuvant therapy is defined as first-line treatment and cannot be included in this study.If a recurrence occurs more than 6 months, the adjuvant treatment plan shall not be included in the treatment plan. 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, no g-csf and other hematopoietic stimulating factors were used for correction) WBC > 4.0 x 109 / L; ANC =1.5 x 109 / L; PLT = 80 x 109 / L; Hb =80 g/L (2) biochemical examination shall meet the following standards: BIL 50 ml/min (Cockcroft - Gault) 7. Surgery was performed more than 4 weeks ago and the wound was completely healed 8. Heart function was good, no myocardial infarction occurred within the half year, and hypertension and other coronary heart diseases were under control. 9. There were no other uncontrolled benign diseases such as lung, kidney, liver, infection, etc.; 10.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 11. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Other uncured malignant tumors in the past or at the same time, except the cured skin basal cell carcinoma and cervical carcinoma in situ; 2. High blood pressure and failure to be reduced to normal range by antihypertensive drugs( Systolic pressure>140mmHg, Diastolic pressure >90mmHg) 3. Allergic to medicines and/or excipients in this program; 4. Coagulopathy (INR>1.5×ULN; APTT>1.5×ULN), with bleeding tendency; 5. Significant clinical significance of bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or patients with vasculitis, etc.; 6. Has the following cardiovascular disease: II class cardiac insufficiency;(including QTc interphase male= 450, female =470 ms); According to NYHA, III~IV cardiac insufficiency, or echocardiography reveal LVEF < 50%; 7. Arteriovenous thrombosis events occurring within 12 months, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc.; 8. Chronic unhealed wounds or fractures; 9. Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks; 10. Have significant impacts on oral absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 11. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months; 12. urine protein= ++, or the 24-hour urine protein content =1.0 g; 13. Active infections requiring antimicrobial treatment (e.g. those requiring antimicrobial, antiviral and antifungal treatment); 14. Have a history of psychotropic substance abuse and be unable to quit or have a mental disorder; 15. Participated in other clinical trials of anti-tumor drugs within 4 weeks; 16. Patients who received strong CYP3A4 inhibitor treatment within 7 days or received strong CYP3A4 inducer treatment within 12 days; 17. Women who are pregnant or breastfeeding; Persons with fertility who are unwilling or unable to take effective contraceptive measures; 18. 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
Public ContactChen Xiao
Lanzhou University Second Hospital
Outcome results
None listed