Resectable locally advanced gastric/gastric-cardiac junction adenocarcinoma (cT4a >= 4cm or cN2-3)
Conditions
Interventions
Experimental group:Intraoperative placement of the abdominal chemotherapy port and postoperative prophylactic intraperitoneal normothermic chemotherapy
Control group:none
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed gastric/gastroesophageal junction adenocarcinoma; 2. Resectable by CT assessment and meets at least one of the following: cT4a, tumor maximum diameter >= 4 cm, or cN2-3, estimated metastatic lymph nodes >= 3; 3. No distant metastasis (cM0); 4. Esophageal invasion = 18 years, ECOG PS 0-1; 6. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy; 7. Not residual gastric cancer or recurrent cancer; 8. Laparoscopic exploration P0/CY0; 9. No need for combined thoracoabdominal incision, Appleby procedure, or combined pancreaticoduodenectomy; 10. No gastrointestinal obstruction; 11. Major organ function meets criteria (ANC >= 1.5 × 10^9/L, PLT >= 100 × 10^9/L, Hb >= 90 g/L, TBil = 50 mL/min); 12. Cohort C: thyroid function and myocardial markers show no clinically significant abnormalities; 13. Negative pregnancy test for women of childbearing potential; subjects agree to use contraception; 14. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of peritoneal metastasis, distant metastasis, or inability to perform radical D2 surgery; 2. Pregnancy or breastfeeding; 3. Other primary malignant tumors within the past 5 years; 4. Emergency surgery or active bleeding; 5. Gastrointestinal perforation within the past 6 months; 6. Cohort C: history of prior anti-PD-1/PD-L1 treatment; 7. Use of anti-tumor traditional Chinese medicine/immune modulators within 2 weeks before the first dose; 8. Severe uncontrolled infection or active HBV/HCV infection; 9. Body temperature >= 38.0°C before administration indicating active infection; 10. Cohort C: systemic glucocorticoids > 10 mg/day prednisone equivalent or systemic immunosuppressive therapy; 11. Cohort C: active autoimmune disease requiring systemic immunosuppressive treatment; 12. Cohort C: history of allogeneic organ/hematopoietic stem cell transplantation (excluding corneal transplantation); 13. Severe uncontrolled underlying diseases (heart disease, interstitial pneumonia, uncontrolled diabetes/hypertension, etc.); 14. Allergy to the study drug; 15. Currently participating in other interventional clinical studies; 16. Investigator deems unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;disease-free survival;Peritoneum recurrence-free survival and safety; | — |
Countries
China
Contacts
Public ContactChao Yan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed