gastric cancer
Conditions
Interventions
experimental group:treprilumab and sox regime
Sponsors
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-80 years old; 2. Histopathological Imaging comfirmatiom of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma; 3. Histopathological comfirmatiom of unremovable local advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatic adenocarcinoma); 4. ECOG 0-1 points; 5. With adequate organ and bone marrow function, defined as follows: 1) Blood routine: absolute neutrophil count (ANC) >= 1.5x10^9 / L; platelet count (PLT) >= 85 x 10^9 /L; hemoglobin content (HGB) >= 90g / L. 2) Liver function: Patients without liver metastase require serum total bilirubin (TBIL) = 60mL / min 4) Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) 6 months; 8. expected survival time >= 12 weeks; 9. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age, should carry effective contraceptive measures throughout the treatment period and 6 months after the treatment period; 10. The patients voluntarily joined the study, signed informed consent, and were able to follow the program's visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Diagnosed as HER2-positive stomach adenocarcinoma; previously exposed to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other T-cell co-stimulation or an antibody or drug whose checkpoint pathway is a specific target; has been previously treated systematically for advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. 2. Participate in another interventional clinical study, unless involved in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 3. patients with autoimmune diseases or abnormal immune system; known history of allogeneic organ transplantation and history of allogeneic hematopoietic stem cell transplantation; 4. uncontrollable hypertension, diabetes, heart disease; 5. The proximal obstruction of the cardia and pylorus affects the patient's eating and gastric emptying, or obstruction of swallowing pills; it is known that endoscopic signs of active bleeding in the lesion; 6. known to have active tuberculosis; with interstitial lung disease requiring steroid therapy; 7. A history of human immunodeficiency virus (HIV) infection (ie HIV antibody positive) is known; it is known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load >= 200 IU/mL or >= 103 copies) Number/mL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive); 8. serious infections that are active or have poor clinical control; 9. Other history of primary malignancies, except for non-melanoma skin cancer or malignant freckle-like sputum that was completely relieved for at least 2 years before enrollment and without additional treatment during the study; adequately treated and without evidence of disease recurrence; In situ carcinoma that is well treated and has no evidence of disease recurrence. 10. Female patients who are pregnant or breastfeeding. 11. It is known to be allergic to any monoclonal antibody or chemotherapeutic drug (Tigio, oxaliplatin) preparations (allergic reactions of grade 3 and above); 12. clinically significant ascites, including any ascites that can be found on a physical examination, ascites that have been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be enrolled. A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or a patient who has caused drainage due to respiratory dysfunction. 13. Other acute or chronic disease, mental illness, or laboratory test abnormalities that may result in the following results: increase the risk of study participation or study drug administration, or interfere with the interpretation of the study results, and rank patients according to the investigator's judgment Is not eligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Duration of remission, DOR;progression-free survival, PFS;overall survival, OS; | — |
Countries
China
Contacts
Public ContactXiuying Xiao
Department of Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Outcome results
None listed