Gastric cancer
Conditions
Interventions
NA:sintilimab combined with FLOT4 regimen
Sponsors
the Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to implementing any trial-related procedures; 2. Aged 18 - 75 years; 3. Histologically proven adenocarcinoma of the stomach, the primary tumor locates in the stomach clinical cT3-4aN1-3M0 disease according to 8th edition of AJCC, confirmed by enhanced contrast abdominal computed tomography (CT) or magnetic resonance imaging (MRI). At least one measurable lesion. Resectable gastric cancer, judged by surgeons in this study; 4. No previous systemic treatment for the current disease, including surgery, anti-tumor chemoradiotherapy, immunotherapy, etc.; 5. Eligible and reasonably suitable for potentially curative resection; 6. ECOG performance status 0-1; 7. Expected survival time > 6 months; 8. Adequate organ function, the subject will meet the following laboratory criteria: (1) Absolute neutrophils (ANC) were >= 1.5 x 10^9/L in the absence of colony stimulating factor for the last 14 days; (2) Platelet >= 100 x 10^9/L; (3) Hemoglobin > 90 g/L; (4) Total bilirubin 1.5 x ULN but direct bilirubin = 60 mL/min; (7) Coagulation function was good and was defined as an international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Subjects with normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range if baseline TSH is outside the normal range, can be enrolled if total T3 (or FT3) and FT4 are within the normal range; (9) The myocardial enzyme profile within the normal range (if the investigator comprehensively determines that the simple laboratory abnormality is not clinically significant, it is allowed to be included).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radically resected carcinoma in situ); 2. Received other study drugs within 4 weeks prior to initial dosing; 3. Received antibiotics or similar products in the last 1 month or used pharmaceutical grade intestinal microbiota regulation products; 4. Prior treatment: anti-PD-1 anti-PD-L1 or anti-PD-L2 drugs or drugs that are another stimulating or co-inhibiting T-cell receptor (including but not limited to CTLA-4 OX-40 CD137, etc.); 5. Received systemic therapy of proprietary Chinese medicines with antitumor indications or immunomodulatory agents (including thymosin interferon interleukin, except for local use to control pleural effusion) within 2 weeks prior to initial administration; 6. Replacement therapy for an active autoimmune disease (e.g. thyroxine insulin or physiologic glucocorticoids for adrenal or pituitary insufficiency) that has occurred within 2 years prior to initial administration requiring systemic therapy (e.g. use of disease-relieving drugs such as glucocorticoids or immunosuppressants) is not considered systemic therapy; 7. Receiving systemic glucocorticoid therapy (excluding nasal inhalation or other topical glucocorticoid injection) or any other form of immunosuppressive therapy within 7 days prior to initial dosing; Note: Physiological doses of glucocorticoids (10 mg/ day of prednisone or equivalent) are permitted; 8. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known; 9. Allergy to drugs used in this study is known; 10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of the normal value in the laboratory department of the research center); Note: hepatitis B subjects who meet the following criteria can also be enrolled: (1) HBV viral load before initial administration class 2 chronic heart failure; (3) Any arterial thromboembolism or ischemia, such as unstable angina with myocardial infarction or transient ischemic attack, occurred in the 6 months prior to inclusion; (4) Active pulmonary tuberculosis; (5) There are active or uncontrolled infections that require systemic treatment; (6) liver diseases such as cirrhosis and decompensated liver disease; (7) Routine urinal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;ctDNA changes in circulating tumors before and after neoadjuvant therapy and its correlation with neoadjuvant therapy (FLOT4 combined with sindilizumab); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical descending rate (T and/or N descending);Major pathological response rate;Objective response rate (ORR) and disease control rate (DCR);Disease free survival (DFS);overall survival (OS); | — |
Countries
China
Contacts
Public ContactJi Gang
the Air Force Military Medical University
Outcome results
None listed