gastric cancer
Conditions
Interventions
Test group:Cadonilimab 10mg/kg iv drip,d1 q3w
3 cycles
Oxaliplatine 130mg/m2 iv drip,d1 q3w 3cycles
S-1 40-60mg bid d1-d14 q3W 3cycles
Sponsors
Department of Oncology, The First People's Hospital Affiliated to Yangtze University,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female aged 18-70 years 2. Gastric adenocarcinoma confirmed by biopsy histology. HER2 was negative based on IHC, According to AJCC 8th Edition, cTNM was diagnosed as cT3-4N+M0 according to endoscopic ultrasonography or enhanced CT / MRI, and the lesions could be resected; 3 According to RECIST v1.1 standard, there is at least one assessable lesion; 4 No history of chemotherapy , radiotherapy or immunetherapy before diagnosis 5. ECOG score was 0-1; 6 There was no surgery contraindications 7. Patients with an expected survival time of more than 6 months; 8. There was no significant abnormality in routine laboratory examination (blood routine, liver and kidney function, coagulation function, etc.) (1) The blood routine examination standard should meet (no blood transfusion and blood products within 14 days) ANC >= 1.5 * 10^9/L PLT >= 80 * 10^9/L (2) Biochemical examination should meet the following standards: TBIL 45 ml / min (Cockcroft Gault formula); (3)TSH is normal, LDHASTCK-MB is normal 9. Female patients of childbearing age need to exclude pregnancy; 10. The subjects volunteered to join the study and signed the informed consent. They had good compliance and cooperated with the follow-up
Exclusion criteria
Exclusion criteria: Patients with active malignant tumor in recent 5 years, except cured localized tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ 2. tumor tissue from biopsy showed HER-2 positive (IHC ++?+++ or FISH positve) 3. Patients with active bleeding 4.Concurrent participation in another therapeutic clinical study 5. Patients who have previously received anti-PD-1 or PD-L1 or CTLA-4 or car-t immunotherapy; 6. Patients with any active autoimmune disease or history of autoimmune diseases 7. The subjects were using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression , and continued to use them within 1 weeks before enrollment; 8. Patients with acute cardiovascular and cerebrovascular diseases, such as acute cerebral infarction and acute coronary syndrome, have not been well controlled; 9. Patients with history of allogeneic organ transplantation or allohematopoietic stem cell transplantation 10. Known human immunodeficiency virus (HIV) infection 11. . Untreated active hepatitis B ( HBsAg positive and The copy number of HBV-DNA is greater than the upper limit of normal values in the laboratory of the research center), Hepatitis B patients who meet the following criteria can also be included in the group: a)Before the first administration, if the HBV viral load is < 200 IU/ml, subjects should receive anti HBV treatment throughout the entire study. b)Patients with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored; 12.Previous treatments that have residual toxicity (such as hematological, cardiovascular, or neurotoxic levels = 2) 13. The researchers think it is not suitable to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response ;R0 resection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response ; | — |
Countries
China
Contacts
Public ContactLi Shuang
The First People's Hospital Affiliated to Yangtze University, Jingzhou
Outcome results
None listed