pathological stage III (pIII) gastric adenocarcinoma and gastroesophageal junction adenocarcinoma after surgery.
Conditions
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The research participants voluntarily joined this study, signed the informed consent form and demonstrated good compliance. 2. Age >=18 years old and =4000/mm^3 or >= the lower limit of the normal value (LLN) at the research center; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Hemoglobin (HGB) >=9.0 g/dL. 2) Liver function: Serum total bilirubin (TBIL) 60mL/min(Cockcroft-Gault formula);Urinalysis showing protein =2+, 24-hour urine collection should be performed with 24-hour quantitative urine protein <1g. 4) Coagulation function: International Normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times ULN. 12. Female patients of childbearing age or male patients whose sexual partners are female of childbearing age must take effective contraceptive measures throughout the treatment period and for at least 6 months after the last medication, and must not breastfeed.
Exclusion criteria
Exclusion criteria: 1. Gastric cancer patients who had received non-surgical anti-tumor treatment (such as radiotherapy, chemotherapy or hormone therapy) before enrollment. 2. Weight loss >=15% from pre-surgical baseline at the time of first study drug administration. 3. Patients with dysphagia or known drug malabsorption. 4. History of other malignancies within 5 years prior to enrollment, excluding surgically cured skin basal cell or squamous cell carcinoma, or cervical carcinoma in situ. Detection of a second primary malignancy at enrollment, or history of other malignancies within 5 years prior to enrollment (excluding adequately treated skin basal cell carcinoma or cervical carcinoma in situ). 5. Presence of uncontrolled post-operative complications at enrollment (such as post-operative infection, suture dehiscence, gastrointestinal bleeding, or pancreatic leak). 6. Current or past history of severe allergic reactions to any other antibody products. 7. Presence of any active autoimmune disease, or history of chronic or recurrent autoimmune disease (exclusion required). However, patients with Type 1 diabetes, hypothyroidism controlled with hormone replacement therapy, and skin conditions (such as vitiligo, psoriasis, alopecia) not requiring systemic treatment are permitted to enroll. 8. Severe pulmonary disease (interstitial pneumonitis, pulmonary fibrosis, severe emphysema, etc.) within 4 weeks prior to enrollment. 9. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C, etc. (Previous history of hepatitis B virus infection, whether controlled by drugs or not, HBV DNA>=10^4 × copy number or >=2000IU/mL). 10. Systemic corticosteroids (except for temporary use, such as for examination, prevention of allergic reactions or reduction of radiotherapy-related edema) or immunosuppressants are required or received within 28 days before enrollment. 11. Presence of pericardial effusion, pleural effusion, or ascites requiring treatment. 12. Active ulcers of the stomach and duodenum, ulcerative colitis, intestinal obstruction, other gastrointestinal diseases, or active bleeding from unresected tumors prior to enrollment, or other conditions that may lead to gastrointestinal bleeding or perforation as determined by the investigator; or history of intestinal perforation or intestinal fistula without complete recovery from surgery. 13. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or evidence or history of bleeding tendency (regardless of severity) within 2 months prior to enrollment. 14. Stroke or transient ischemic attack occurred within 12 months before enrollment. 15. Acute myocardial infarction, severe/unstable angina, or coronary artery bypass graft within 6 months prior to enrollment; patients with New York Heart Association (NYHA) heart failure class 2 or above. 16. Skin wounds, surgical sites, traumatic sites, severe mucosal ulcers or fractures that have not fully healed. 17. Receiving or requiring anticoagulant therapy (except antiplatelet therapy, including low-dose aspirin). 18. Uncontrolled hypertension prior to enrollment, defined as: systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg; history of hypertensive crisis or hypertensive encephalopathy. 19. Uncontrolled diabetes mellitus. 20. Systemic infection requiring treatment. 21. Contraindications to study medications. 22. Any surgery other than for gastric cancer (any surg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);recurrence-free survival;2-year recurrence-free survival rate;1-year recurrence-free survival rate;Safety and tolerance;3-year Overall Survival(OS) Rate; | — |
Countries
China
Contacts
Public ContactTing Li
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed