Gastric Cancer
Conditions
Interventions
The HIPEC plus XELOX Chemotherapy and Sintilimab Immunotherapy Arm:Following diagnostic laparoscopy, patients will undergo three cycles of Oxaliplatin and Paclitaxel Hyperthermic Intraperitoneal Chemo
Sponsors
Department of Gastric Surgery, Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of peritoneal metastasis by laparoscopic exploration, PCI =18 years and =1.5×10^9/L; Platelet count>=100×10^9/L; Hemoglobin content>=9.0 g/dL; 8. Liver function: serum total bilirubin (TBIL) = 50mL/min; The urine dipstick test result showed that the urine protein was 3 months; 14. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 15. 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% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug); 16. Signed written informed consent and able to comply with the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria cannot be enrolled in this study: 1. Near-obstruction of the cardia and pylorus affecting the patient's eating and gastric emptying, or having difficulty swallowing tablets; 2. Diagnosed with HER2-positive adenocarcinoma of the stomach and gastroesophageal junction. Prior systemic therapy for advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction; 3. Presence of other distant metastases (e.g., liver, lung, pleura, brain, bone metastases, etc.) other than peritoneal metastases determined by the investigators, segmental obstruction of the small intestine, interaction between the tumor and the small intestine and mesangium, and > diameter visible on the surface of the small intestine or mesangium5cm tumor nodules; 4. Known signs of active bleeding of the lesion under endoscopy; 5. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 6. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors (e.g., CTLA-4, OX-40, CD137); 7. Received systemic systemic therapy with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (including thymus peptide, interferon, interleukin, except for topical use for the control of pleural effusion) within 2 weeks prior to the first dose; 8. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 9. Systemic glucocorticoid therapy (excluding nasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; 10. Note: Physiologic doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed; 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Those who are known to be allergic to the active ingredients or excipients of sintilimab and bevacizumab of this study; 13. Have not recovered adequately from toxicity and/or complications caused by any intervention prior to initiation of treatment (i.e., <=Grade 1 or at baseline, excluding fatigue or alopecia); 14. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 15. Untreated active hepatitis B (defined as HBsAg positive and detected HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); 16. Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 17. HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment period to avoid viral reactivation 18. Prophylactic anti-HBV therapy is not required for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), but close monitoring for viral reactivation is required 19. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 20. Vaccination of a liv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 Resection (Assessment of Residual Tumor); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Event-Free Survival;Relapse-Free Survival;Security; | — |
Countries
China
Contacts
Public ContactYingbo Chen
Sun Yat-sen University Cancer Center
Outcome results
None listed