Gastric cancer
Conditions
Interventions
Test group :DS-1 in combination with cadonilimab
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join this study and sign informed consent; 2. Aged 18-75 years, both male and female; 3. Patients with stage pIIIb-IIIc gastric cancer who have pathologically or histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and undergo radical resection (D2 lymph node dissection). (TNM staging, 8th UICC/AJCC); 4. ECOG score: 0~1; 5. Have not received prior systemic therapy for current diseases, including anti-tumor chemoradiotherapy/immunotherapy, etc; 6. There was no peritoneal metastasis during intraoperative exploration, and cytological analysis showed that ascites exfoliated cells were negative (CY0P0); 7. Postoperative biomarker detection of gastric cancer specimens showed that PD-L1 CPS 6 months; 9. Adequate organ function, subjects need to meet the following laboratory indicators: (1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) >= 1.5x10^9/L; (2) In the case of no blood transfusion in the past 14 days, platelet >= 100x10^9/L; (3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; (4) Total bilirubin = 60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all participants (male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic agent).
Exclusion criteria
Exclusion criteria: 1. Subject withdraws informed consent and asks to withdraw; 2. Patients with strong positive HER2 expression and ERBB2 gene amplification were excluded; 3. EBER positive EBER patients with EBVaGC are excluded; 4. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 5. Untreated active hepatitis B (defined as HBsAg positivity and detection of HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Subjects with hepatitis B who meet the following criteria may also be enrolled: HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment period to avoid viral reactivation; For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) , prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored; 6. Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection); 7. Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 8. Those who are unable to tolerate toxicity; 9. Poor subject compliance; 10. Subject lost to follow-up or pregnant; 11. Other conditions that, in the opinion of the investigator, necessitate withdrawal from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival;3-year recurrence-free survival;3-year overall survival;Safety and incidence of treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactZhang Zizhen; Yue Ben
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed