Gastric cancer, esophageal gastric junction cancer
Conditions
Interventions
therapy group:Simultaneous radiotherapy and chemotherapy combined with adelbilimumab
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18 and 75 years old (including 18 and 75 years old); 2. Understand the research steps and content, and voluntarily sign a written informed consent form; 3. Gastric or gastroesophageal junction adenocarcinoma or squamous cell carcinoma confirmed by histopathology and/or cytology as HER2 negative or with unknown HER2 status, clinically classified as T3-4aN+M0 stage by imaging evaluation such as endoscopic ultrasound and CT/MRI. 4. According to the requirements of RESIST 1.1, there should be at least one abdominal CT/MRI assessable lesion; 5. Have not received treatment with PD-1/PD-L1 monoclonal antibody in the past; 6. ECOG 0-1 points; 7. The main organ function is good, and the relevant examination indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 80 g/L (no blood transfusion within 14 days); Neutrophil count>1.5 × 10^9/L; Platelet count >= 70 × 10^9/L; Total bilirubin = 60 mL/min (Cockcroft Goult formula); Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= 50%; 8. Thyroid function indicators: Thyroid stimulating hormone (TSH) and free thyroxine (FT3/FT4) within the normal range or with slight and clinically insignificant abnormalities; 9. Sign an informed consent form, with no other surgical contraindications, and agree to provide blood and histological samples.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Women of childbearing age tested positive in baseline pregnancy tests; 3. Diagnose distant metastasis through CT/MR/EUS; 4. Received previous anti-tumor treatments, including chemotherapy, radiotherapy, or immunotherapy; 5. Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years; 6. Uncontrollable pleural effusion, pericardial effusion, or ascites; 7. Suffering from severe cardiovascular diseases within the 12 months prior to enrollment, such as symptomatic coronary heart disease, >= grade II congestive heart failure, uncontrolled arrhythmias, and myocardial infarction; 8. Concurrent upper gastrointestinal obstruction/bleeding, digestive dysfunction or malabsorption syndrome may affect the absorption of capecitabine; 9. Severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; 10. Allergic reactions to the drugs used in this study; 11. Administer steroids or other systemic immunosuppressive therapies 14 days prior to enrollment; 12. Patients who received study drug treatment within 4 weeks prior to enrollment (participating in other clinical trials). 13. Active autoimmune diseases. 14. History of primary immunodeficiency. 15. Within 4 weeks prior to the first dose of study treatment, immunosuppressive drugs were used, excluding local corticosteroids administered through nasal spray, inhalation, or other routes, or systemic corticosteroids administered at physiological doses (i.e. no more than 10mg/day of prednisone or equivalent doses of other corticosteroids), or steroids were used to prevent contrast agent allergies. 16. Within 4 weeks prior to the first dose of study treatment or planned to receive attenuated live vaccines during the study period. 17. Known to have active pulmonary tuberculosis. 18. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 19. HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV). 20. Other researchers determine that the requirements are not met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR) ;Major Pathologic Response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Year Recurrence-Free Survival (RFS) ;Incidence of Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactMingxia Zhang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed