Gastric/ gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:Adbelizumab + Apatinib mesylate +SOX
Sponsors
Changshu Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years (including 18 and 75 years); 2. Understand the research procedure and content, and voluntarily sign a written informed consent; 3. Histologically or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma; 4. No serious liver and kidney function damage, organ function level must meet the following requirements: ANC = 1.5×109/L; PLT = 90×109/L; Hb = 90 g/L; TBIL = 1.5×ULN; ALT and AST = 1.5×ULN, ALP = 2.5×ULN; For patients with liver metastases, ALT and AST = 5×ULN; BUN and Cr = 1×ULN and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); LVEF = 50%; Fridericia corrected QT Interval (QTcF) < 450 ms for males and < 470 ms for females; INR = 1.5×ULN, APTT = 1.5×ULN; 5. Have at least one measurable lesion according to RECIST 1.1 criteria; 6. No previous treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibody. Patients who had received platinum or paclitaxel or fluorouracil adjuvant chemotherapy after surgery and recurred more than 6 months after the end of chemotherapy without grade 2 toxicity or higher could be enrolled. 7. Physical condition score (ECOG PS score) : 0-1 score; 8. Expected survival =3 months; 9. The investigator assessed that the patient could comply with the protocol requirements; 10. Sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors in the past or at the same time, but have been cured of early tumors, including skin basal cell carcinoma and cervical carcinoma in situ, stage I lung cancer, stage I colorectal cancer and other early tumors that do not affect the life of patients in the short term after radical treatment can be excluded. 2. Participated in other drug clinical trials within four weeks; 3. Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 4. Have a history of bleeding and any bleeding event with a severity rating of 3 or above in CTCAE4.0 occurred within 4 weeks prior to screening; 5. Patients with known or history of central nervous system metastasis prior to screening. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to rule out CNS metastasis. 6. Patients with hypertension who are not well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: =450 ms in men and =470 ms in women) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; 7. Long-term unhealed wounds or incomplete healing fractures; 8. Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding; 9. Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs; Low doses of warfarin (1 mg orally, once daily) or low doses of aspirin (up to 100 mg daily) are permitted for prophylactic purposes if INR = 1.5; 10. Arterial/venous thrombosis events occurred within 6 months prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and cured by researchers) and pulmonary embolism; 11. Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein quantity > 1.0g; 12. Used immunotargeted therapy drugs; 13. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 14. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; 15. History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; History of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, irritable bowel syndrome and other chronic diarrheal diseases; A history of sarcoidosis or tuberculosis; History of active hepatitis B, hepatitis C and HIV infection; Well controlled non-severe immune diseases such as dermatitis, arthritis, psoriasis, etc. can be included. Hepatitis B virus titer < 500copy/ml could be included in the group. 16. Patients with hypersensitivity to human or murine monoclonal antibodies; 17. Those who have a h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;DoR;Safety; | — |
Countries
China
Contacts
Public ContactYulan Gu
Changshu Second People's Hospital
Outcome results
None listed