Locally advanced HER2-negative adenocarcinoma of the stomach or gastroesophageal junction
Conditions
Interventions
experimental group:Apololitowereili Monoclonal Antibody combined with FLOT regimen
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70, male or female; 2. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1; 3. Patients with newly diagnosed stage IIB-III (cT3, N+, M0 and cT4a, Nany, M0, according to the 8th edition of the AJCC staging manual) adenocarcinoma of the stomach and gastroesophageal junction (GEJ, as defined in the Siewert classification system, with the tumor center located within 5 cm proximal and distal to the anatomical location of the cardia), who are considered resectable by the investigator and may undergo staging laparoscopy if necessary to rule out occult peritoneal metastasis; 4. Within 3 months before enrollment, the tumor was confirmed to be MSS/MSI-L type HER2-negative by the central laboratory, defined as IHC 0/1+ or IHC 2+/ISH negative (in accordance with the guidelines of the College of American Pathologists (CAP) and the Chinese Society of Clinical Oncology (CSCO)), and the combined positive score (CPS) of PD-L1 protein expression was >=1. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there must be at least one measurable lesion; 6. Normal function of important organs, and no use of granulocyte colony-stimulating factor, cytokines, blood transfusion or other corrective treatments within 14 days before enrollment, meeting the following criteria: a. Blood routine: Absolute neutrophil count (ANC) >= 1.5×10^9/L; platelet (PLT) >= 90×10^9/L; hemoglobin (Hb) > 90g/L (if the decrease in hemoglobin is clearly due to bleeding from the tumor itself and other factors are excluded, it can be relaxed to Hb > 80g/L); b. Liver function: Total bilirubin (TBIL) = 1.5×ULN (for Gilbert's syndrome patients = 60 mL/min (Cockcroft-Gault formula); d. Coagulation function: Defined as activated partial thromboplastin time (APTT), international normalized ratio (INR) or prothrombin time (PT) = 50%; myocardial enzymes within normal range (if the researcher comprehensively determines that the laboratory abnormality is not clinically significant, enrollment is also allowed). 7. Expected survival of at least 3 months; 8. Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptive pills or condoms) during the study period and within 6 months after the study. They must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be lactating. Men must agree to use contraceptive measures during the study period and within 6 months after the study; 9.Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pathological histological or cytological examination confirmed other pathological types, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc. Mixed pathological types will be judged based on the main component. If the adenocarcinoma component is confirmed to be more than 70% by a pathologist, it can be included in the group; 2. Any previous systemic or local treatment for gastric or gastroesophageal junction adenocarcinoma, including but not limited to chemotherapy, radiotherapy, surgery, etc. 3. Have previously received anti-PD-1, anti-PD-L1, anti-CTLA-4 or other immunotherapy; 4. Other malignant tumors have occurred within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer. 5. Patients known to be allergic to any study drug or drug excipient; 6. Within 6 months prior to the first administration, there were clinically significant events such as gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess, fistula formation, etc. 7. Active, uncontrolled or recurrent inflammatory gastrointestinal diseases exist; 8. There is pleural effusion, pericardial effusion or ascites with clinical symptoms that require treatment and/or repeated drainage; 9. Major surgery, significant trauma, or unhealed or poorly healed wounds or complications from wound treatment within 4 weeks prior to the first dose administration; 10. Major cardiovascular diseases, including any of the following conditions: a) Congestive heart failure (defined as New York Heart Association (NYHA) Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery bypass grafting, cerebrovascular accident (CVA), or uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy) within 6 months prior to enrollment; b) History of clinically significant ventricular arrhythmias; c) Fridericia-corrected QT interval (QTcF) > 450 milliseconds (msec) in men or > 470 msec in women; d) History or family history of congenital long QT syndrome; e) Arrhythmias requiring antiarrhythmic drug treatment; f) History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within 3 months prior to enrollment (implantable venous access port or catheter-related thrombosis, or superficial venous thrombosis is not considered a "serious" thromboembolic event); 11. Patients with uncontrolled diabetes, peripheral neuropathy of grade II or above, severe myelosuppression, abnormal liver function [Child-Pugh B or C cirrhosis; a history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, that is, HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (>1×10^3 copies/mL)], or abnormal renal function (urine routine test indicates urine protein >2+, or 24-hour urine protein quantification >1.0g) are excluded during screening; 12. Uncontrolled systemic infection or systemic anti-infective treatment within 4 weeks before the first administration; 13. Active infectious diseases, such as AIDS/active syphilis, etc. 14. Within 7 days before the first administration or currently continuously taking non-steroidal anti-inflammatory drugs, antiplatelet dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor regression grade;Event-free survival period;Surgical resectability rate, R0 resection rate;Safety indicators: Adverse events and serious adverse events;Overall survival period; | — |
Countries
China
Contacts
Public ContactLiangjie Chi
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed