Gastric cancer
Conditions
Interventions
Experimental group:Sox combined with envolimab (PD-L1 mAb) in neoadjuvant treatment
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical research; Fully understand and know the study and sign informed consent form (ICF); Willing to follow and able to complete all test procedures; 2. There is no limit on gender, and the age when signing ICF is >= 18 years old and = T3 and the number of lymph node metastasis >= N2, and there was no distant metastasis; 6. Before enrollment, the attending doctor shall evaluate to determine the research qualification for R0 resection for the purpose of cure; 7. The heart function is good and can be resected for the purpose of cure. If clinically indicated, patients with underlying ischemic, valvular heart disease, or other severe heart diseases should be evaluated preoperatively by a cardiologist; 8. Subjects must provide the time of enrollment (repeated screening subjects do not need to be tested for PD-L1 again) and the tumor tissue (if any) operated in this study for PD-L1 expression level determination; Note: the subject must provide tumor tissue samples collected at the lesion site and fixed with formalin on or after the diagnosis of GC (within 6 months before the first study medication is recommended). Paraffin embedded tumor specimens (preferred) or unstained freshly cut continuous tissue sections (preferred anti detachment slides). Relevant pathological reports of the above specimens must also be provided. If the subject does not have qualified archived tumor tissue samples, he must undergo fresh tumor focus biopsy during the screening period to obtain corresponding tumor samples (the number of samples obtained depends on the biopsy). Freshly collected specimens, resection, hollow core biopsy, resection, incision, stamping or clamp biopsy are all within the acceptable range (newly obtained tissue is preferred). Needle aspiration samples (i.e. samples lacking complete tissue structure and only providing cell suspension and/or cell smear), brush coated samples, and cell precipitation samples from pleural or peritoneal effusion are not accepted. See the laboratory operation manual for the requirements of tissue samples. 9. Anti-tumor traditional Chinese medicine, Chinese patent medicine and immunomodulator (such as thymosin, lentinan, interleukin-12, etc.) used in the past must be >= 2 weeks from the end of the study; 10. ECoG PS score within 7 days before the first medication was 0 or 1; 11. Estimated survival time >= 3 months; 12. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus DNA (HBV-DNA) must be < 1000 copies /mL or < 200 IU/mL or < the normal upper limit of study center (ULN); 13. The main organs function normally, i.e. they meet the following criteria (they have not received blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor (CSF) treatment
Exclusion criteria
Exclusion criteria: 1. Other active malignant tumors within 5 years or at the same time. Limited localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, in situ carcinoma of the cervix, and breast cancer in situ, can be included; 2. Patients who are ready for or have previously received organ or bone marrow transplantation; 3. The interval of cardiac arrhythmia (including QTc >= 470 MS in men and QTc >= 6 months in women) was calculated according to the formula before the first myocardial infarction; 4. There is NYHA standard grade III-IV cardiac insufficiency or color Doppler echocardiography: LVEF (left ventricular ejection fraction) 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days before the first medication or during the study. However, the following conditions are allowed to be included: in the absence of active autoimmune diseases, patients are allowed to use local topical or inhaled steroids, or adrenal hormone replacement therapy with the effective dose of prednisone <= 10 mg/day; 11. Any active infection requiring systemic anti-infective treatment within 14 days before the first medication; Except for prophylactic antibiotic treatment (such as prevention of urinary tract infection or chronic obstructive pulmonary disease); 12. Previously received other antibody/drug treatments against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.; 13. Being treated in other clinical studies or planning to start the treatment of this study is less than 14 days from the end of the treatment of the previous clinical study; 14. Known history of severe allergy to any monoclonal antibody or study drug excipients; 15. Known history of psychotropic substance abuse or drug abuse; Patients who have stopped drinking can be enrolled; 16. There are patients who may increase the risk of participating in the study and study medication, or other severe, acute, and chronic diseases, and are judged by the investigator to be unsuitable for participating in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological reaction rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival ;Objective remission rate ;R0 resection rate;Relationship between ctDNA expression and efficacy and distant metastasis; | — |
Countries
China
Contacts
Public ContactHao Wu
Jiangsu Province Hospital
Outcome results
None listed