gastric adenocarcinoma
Conditions
Interventions
observational group:TDS regimen: Tislelizumab (T) + Docetaxel (D) + S-1 (S)
Tislelizumab 200 mg ivgtt d1 + Docetaxel 40 mg/m^2 ivgtt d1 + S-1 40-60 mg po bid D1-14, once every three weeks for 8 cycles
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent before implementing any procedures related to the trial; 2. Age =18 years old and =75 years old, gender is not limited; 3. Histopathologically confirmed gastric/gastroesophageal junction adenocarcinoma; 4. Radical gastrectomy with D2 or above was performed after neoadjuvant chemotherapy, and R0 resection was achieved. The postoperative pathological evaluation was TRG=3. 5. PD-L1 CPS = 1; 6. ECOG score 0-1; 7. For adequate organ function, subjects must meet the following laboratory criteria: 1) In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) was =1.5x10^9/L. 2) Platelets =100×10^9/L in the past 14 days without blood transfusion. 3) In the case of no blood transfusion or use of erythropoietin in the last 14 days, hemoglobin >9g/dL; 4) Total bilirubin =1.5× upper limit of normal (ULN); 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2.5×ULN (ALT or AST =5×ULN for subjects with liver metastasis); 6) Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; 7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 8. For female participants of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all participants (male or female) are required to use a contraceptive with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Known Her-2 positive test; 2. M1 (including CY1); 3. Malignant diseases other than gastric and gastroesophageal junction adenocarcinoma diagnosed within 5 years prior to initial administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous epithelial carcinoma, and/or radical resection of carcinoma in situ); 4. Patients currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 5. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 6. Received treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control ascites) within 2 weeks before the first administration; 7. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 8. Receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) is permitted; 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Patients who are known to be allergic to the active ingredients or excipients of other chemotherapeutic drugs such as PD-1 inhibitor, S-1, capecitabine, oxaliplatin and docetaxel; 11. Having multiple factors that affect oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction, and near-obstruction of the cardia and pylorus affecting eating and gastric empting); 12. Not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss); 13. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 14. Uncontrolled active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load <1000 copies /ml (200 IU/ml), participants should receive anti-HBV therapy throughout study drug therapy to avoid viral reactivation 2) For participants with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required 15. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 16. Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted. 17. Pregnant or lactating women; 18. T
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events;2-year/3-year recurrence-free survival rate;1-year/2-year/3-year overall survival rate; | — |
Countries
China
Contacts
Public ContactXiaodong Chen
Sichuan Cancer Hospital
Outcome results
None listed