Locally Advanced Resectable Gastric Cancer
Conditions
Interventions
experimental group:zimberelimab combined with chemotherapy
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. =18 years old; 2. Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology; 3. The primary lesion can be surgically resected, and the patient is willing to undergo surgical treatment; 4. The clinical stage was cT3-4, with lymph node metastasis but no distant metastasis; 5. Measurable solid tumors (according to RECIST 1.1); The tumor should be evaluated by CT scan or MRI within 28 days prior to treatment; 6. All toxic reactions from previous antitumor therapy or surgical procedures releved to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. Except hair loss, fatigue, hearing loss and other toxicities that researchers believe do not pose a safety risk to patients; 7. Participants must have normal organ function, as defined below: -Hemoglobin =9.0 g/dL - Absolute neutrophil count =1.5×109/L - Platelet count =75×109/L - Serum bilirubin =1.5× upper limit of normal (ULN) -alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5×ULN -creatinine clearance (CrCl) =60mL/min, as calculated by the Cockcroft-Gault formula (using actual body weight) or as measured by collected urine at 24 hours. Female: Creatinine CL= Weight (kg) × (140 -- age) ×0.85 (mL/min) 72× serum creatinine (mg/dL) 8. Female subjects of reproductive age must have a negative serum pregnancy test result within 7 days prior to the start of the study medication and be willing to use a medically approved highly effective contraceptive (e.g., IUD, contraceptive or condom) during the study period and within 3 months after the last dose of medication is administered; Male subjects with a female partner of childbearing age should be surgically sterilized or agree to use effective contraceptive methods during the study period and within 3 months after the last study administration; 9. Female participants had to agree not to breastfeed during the study period and for 150 days after the last treatment; 10. Participants must be able to understand study procedures and agree to participate in the study by providing written informed consent; 11. ECOG score 0-1; 12. Life expectancy =6 months
Exclusion criteria
Exclusion criteria: 1. Use of immunosuppressive drugs within 14 days prior to medication, except intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., no more than 10 mg/ day of prednisolone or other corticosteroids at equivalent physiological doses); 2. History of autoimmune disease, idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia, idiopathic pneumonia, or interstitial pulmonary disease with active pneumonia found on chest CT scan. Active tuberculosis; 3. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-lymphocyte antigen 4 (CTLA-4) antibody; 4. Lactating or pregnant women; 5. Known prior allergy to macromolecular protein preparations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy; 6. Patients received live vaccination within 4 weeks prior to the start of treatment; 7. Patients have received anti-tumor vaccine or anti-tumor therapy with systemic immune stimulation; 8. Previous recipients of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 9. History of alcohol, drug or substance abuse within the last 1 year; 10. Patients with confimed history of neurological or mental disorders, such as epilepsy and dementia, and poor compliance; 11. Other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of study participation and study medication, or may interfere with the interpretation of study findings; 12. The following conditions occurred within 6 months prior to medication: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, poorly controlled arrhythmias (including QTcF interval >450 ms in men and >470 ms in women, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism) 13. Participants have a known history of human immunodeficiency virus. 14. The patients considered to be not suitable to participate in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate, MPR;Objective Response Rate,ORR;Surgical resection rate;R0 resection rate;progression free survival,PFS;safety; | — |
Countries
China
Contacts
Public ContactChunning Zheng
Shandong Provincial Hospital
Outcome results
None listed