Locally advanced gastric cancer
Conditions
Interventions
Intervention group:his study is a full-course neoadjuvant therapy clinical trial, which adopts a multi-drug chemotherapy and immunotherapy regimen combining the SOX regimen with tislelizumab. All pati
The sequence of the first administration (if it is administered simultaneously on the same day) is as follows:
Tislelizumab: PD-1 iv drip d1
Q3W (once every three weeks)
Oxaliplatin: 130mg/m2 iv drip, d1
Q3W (once every three weeks)
Teggio: 40-60 mg each time, oral, bid, Day 1-14
Q3W (once every three weeks)
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed HER-2-negative gastric adenocarcinoma, treatment-naïve, with no prior chemotherapy, radiotherapy, or other antitumor therapy before the start of the clinical trial. 2. Age 18-75 years, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 3. Clinical TNM stage (AJCC 8th edition) of cT3N2-3, or cT4aN+, or cT4bNany, without obstruction, perforation, or bleeding risk, and assessed by multidisciplinary team (MDT) as requiring radical gastrectomy. 4. Adequate bone marrow reserve, with complete blood count meeting the following criteria: white blood cell count >=3×10^9/L, absolute neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L. 5. Adequate organ function, with biochemical tests meeting the following criteria: alanine aminotransferase =50 mL/min. 6. International normalized ratio (INR) =2+, 24-hour urine protein quantification must show protein 3 months. 10. Female subjects agree to strict contraception; for male subjects with female partners of childbearing potential, agree to use effective contraceptive methods during the study. 11. Voluntarily sign the informed consent form, and be willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Currently undergoing clinical trials of other drugs or having participated in any drug clinical trials one month before enrollment; 2. Research other anti-tumor treatments besides drugs (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization); 3. Previously used similar chemotherapy drugs or immune checkpoint inhibitors; 4. There are lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, pelvic and abdominal cavities, etc. 5. Gastrointestinal perforation, obstruction or uncontrollable diarrhea occurred within 6 months before enrollment; 6. Other untreated or coexisting tumors, except for cervical carcinoma in situ, treated basal cell carcinoma or superficial bladder tumors. If the tumor has been cured and no evidence of the disease has been found for more than five years, the patient can be enrolled. All other tumors must have been treated for at least 5 years before enrollment; 7. Symptomatic meningioma; 8. History of active autoimmune diseases or refractory autoimmune diseases; 9. Received corticosteroids (> 10mg/d prednisone or equivalent doses of steroids) or other systemic immunosuppressive treatments within 14 days before enrollment, excluding the following treatments: steroid hormone replacement therapy ( New York Heart Association (NYHA) Grade 2; (2) Active coronary artery disease; (3) Arrhythmias that require treatment other than beta-blockers or digoxin; (4) Unstable angina pectoris (with angina pectoris symptoms at rest), new angina pectoris occurring within 3 months before enrollment, or new myocardial infarction occurring within 6 months before enrollment, unhealed wounds, ulcers or fractures; 13. Patients with renal failure who require blood or peritoneal dialysis; 14. Epilepsy patients who need drug treatment; 15. History of organ transplantation (including corneal transplantation); 16. Allergic to or suspected allergic to the research drug or similar drugs; 17. Pregnant or lactating women; 18. Major surgery, open biopsy or major trauma surgery (excluding biliary stents or percutaneous biliary drainage) should be performed 4 weeks before recruitment; 19. Vaccination history in the 4 weeks prior to enrollment; 20. Patients whom the researchers consider unsuitable for study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Major pathological response (MPR);Progression-free survival (PFS);Surgery-related safety;Surgical completion rate;Tumor downstaging rate (TRG);The incidence of adverse reactions during treatment;The influence of the incidence of postoperative adverse reactions;Effective rate of treatment; | — |
Countries
China
Contacts
Public ContactShi Yan
The First Affiliated Hospital of Army Medical University
Outcome results
None listed