Gastric cancer
Conditions
Interventions
Intervention group:Anti-PD1 antibody combined with chemoradiotherapy
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. ECOG 0-1; 3. Histologically confirmed adenocarcinoma of the gastric adenocarcinoma/gastroesophageal junction did not undergo surgical treatment in the past, and did not undergo antineoplastic radiochemotherapy/immunotherapy; 4. Patients were diagnosed as locally advanced without distant metastasis according to AJCC 8th edition, cTNM was diagnosed as cT3,cN2-3 or cT4a, cN+ or cT4b, cNany by endoscopic ultrasonography or enhanced CT/MRI scan; 5. Contraceptive measures should be taken during the trial; 6. The baseline blood routine and biochemical indices of selected patients should meet the following criteria: hemoglobin (>90g/L), absolute neutrophil (>1.5 x 10^9/ L), platelet (>100 x 10^9/ L), aspartate or alanine aminotransferase (<2.5 times the upper limit). Alkaline phosphatase < 2.5 times of normal upper limit (ULN), total serum bilirubin < 1.5 times of ULN, serum creatinine < 1 times of ULN, serum albumin < 30 g/L, INR/PT < 1.5x ULN, aPTT < 1.5x ULN; 7. Sign the informed consent without any other contraindications, and agree to provide blood samples and histological specimens; 8. According to RECIST v1.1, there is at least one measurable lesion.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Women of childbearing age were positive in baseline pregnancy test; 3. Diagnosis of distant metastasis by CT/MR/EUS; 4. Previous antineoplastic treatment, including chemotherapy, radiotherapy or immunotherapy; 5. Other malignant tumors (except basal or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) have been found in the past five years; 6. uncontrollable pleural effusion, pericardial effusion or ascites; 7. Severe cardiovascular diseases, such as symptomatic coronary heart disease, grade II congestive heart failure, uncontrolled arrhythmia and myocardial infarction, occurred within 12 months before admission; 8. Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome may affect the absorption of S-1; 9. Complicated with severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; 10. Allergic reaction to drugs used in this study; 11. Steroids or other systemic immunosuppressive therapy were administered 14 days before admission; 12. Patients receiving research drug treatment within 4 weeks before admission (participating in other clinical trials); 13. Active autoimmune diseases; 14. History of Primary Immunodeficiency; 15. Immunosuppressive drugs were used within 4 weeks prior to the first dose of the study, excluding local glucocorticoids or systemic glucocorticoids (i.e. no more than 10 mg/day prednisone or other glucocorticoids of equivalent dose) through nasal spray, inhalation or other routes, or hormones used to prevent contrast agent allergy; 16. Acceptance of live attenuated vaccine within 4 weeks prior to the first dose of treatment or during the study period is planned; 17. Active pulmonary tuberculosis is known; 18. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation is known; 19. HIV positive, active hepatitis B or C (HBV, HCV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;R0 resection rate;MPR rate;Surgical complication;Disease-free survival;Event-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWei Jia
The Comprehensive Cancer Centre of Drum Tower Hospital
Outcome results
None listed