gastric cancer
Conditions
Interventions
Experimental group:Sintilimab combined with Lenvatinib and XELOX (oxaliplatin and capecitabine) chemotherapy
Sponsors
JiangSu province hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before the implementation of any test-related procedures; 2. Age =18 years old and =75 years old, regardless of gender; 3. Gastric and gastroesophageal junction adenocarcinoma confirmed by histopathological examination; 4. Initial treatment of unresectable locally advanced and potentially resectable gastric cancer patients who are not suitable for concurrent chemoradiotherapy; 5. No previous antitumor therapy (radiotherapy, chemotherapy, targeting or immunotherapy, etc.); 6. During the screening period, CT, MRI, PET-CT, and other examinations suggested only one of the following unresectable factors: 1) Para-aortic lymph node metastasis (No.16a2/b1) 2) Virchow lymph node metastasis 3) Peritoneal oligometastatic: only peritoneal cytological positivity (CY1P0) or peritoneal implantation P1 was visible to the naked eye 7. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there was at least one radiographically measurable lesion; 8. ECOG score 0-1; 9. Expected survival time > 3 months; 10. Adequate organ function, the subject shall meet the following laboratory criteria: 1) The absolute value of neutrophil granulocyte (ANC) =1.5x109/L in the last 14 days without the use of granulocyte colony-stimulating factor. 2) Platelets =100×109/L without blood transfusion in the past 14 days. 3) Hemoglobin > without blood transfusion or use of erythropoietin within the last 14 days; 9g/dL; 4) Total bilirubin =1.5× upper limit of normal value (ULN); 5) Aspartate aminotransferase (AST) and 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 is thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range; 11. For female subjects of childbearing age, a urine or serum pregnancy test should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). A blood pregnancy test is requested if the urine pregnancy test results cannot be confirmed as negative. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 12. If there is a risk of conception, all subjects (male or female) are required to use contraception 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. Distal metastases other than oligometastases defined in the inclusion criteria (e.g. brain, bone, etc.) 2. Positive Her-2 test; 3. Known endoscopic signs of focal active bleeding with a history of gastrointestinal perforation and/or fistula within 6 months; 4. Malignant diseases other than gastric cancer (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical excision) diagnosed within 5 years before initial administration; 5. Currently participating in an interventional clinical study, receiving other investigational drugs, or using investigational devices within 4 weeks before initial dosing; 6. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); Macromolecular antivascular drugs or small-molecule tyrosine kinase inhibitors; 7. Received systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, and interleukin, except for local use to control ascites) within 2 weeks before the first administration; 8. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) occurred within 2 years before initial administration. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 9. Was receiving systemic glucocorticoid therapy (excluding nasal, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the study's initial administration; Note: Physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) are permitted; 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Those who are known to be allergic to the active ingredients or excipients of sintilimab, Lenvatinib, capecitabine, and oxaliplatin of the drugs in this study; 12. Having multiple factors affecting oral medication (e.g. inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, and near-obstruction of the cardiac and pylorus affecting eating and gastric emptying); 13. Has 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); 14. Known history of the human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 15. Uncontrolled active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load < before initial administration; At 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout study drug therapy to avoid viral reactivation 2) For subjects 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 16. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection); 17. The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 Surgical conversion rate;R0 resection rate;1-year OS rate;Primary pathological response rate;pathologic complete response;Objective response rate (ORR);Event free lifetime; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical safety;adverse event; | — |
Countries
China
Contacts
Public ContactXu Tongpeng
JiangSu province hospital
Outcome results
None listed