To treat newly diagnosed HER2-negative gastric/esophagogastric junction adenocarcinoma with peritoneal metastasis
Conditions
Interventions
Experimental group (group A):SOX+ sintilimab group (group A)
Control group (group B):SOX+ sintilimab + albumin paclitaxel intraperitoneal chemotherapy group (group B)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood this research and voluntarily signed the Informed Consent Form (ICF); 2. Patients who were initially diagnosed with adenocarcinoma of the gastric/esophagogastric junction without treatment and were confirmed to have peritoneal metastasis (positive ascites cytology or positive peritoneal nodule pathology) through laparoscopy, with a clinical stage of IV; 3. According to the RECIST (V1.1) standard, there are evaluable or unevaluable lesions. Excluding regional lymph node metastatic lesions, only one or fewer single unresectable metastatic organs are allowed: (1) 1-2 liver metastases of 1-3 cm; (2) Para-aortic a2/b1 metastasis; (3) Ovarian metastasis. 4. Immunohistochemistry shows HER2(0), HER2(1+) or HER2(2+), and FISH test is negative; 5. Agree to provide previously stored tumor tissue specimens or conduct biopsies to collect tumor lesion tissues for sending to the central laboratory for HER2, PD-L1, EBV, and MSI IHC detection; 6. Gender is not limited. Age: 18 to 75 years old; 7. Generally in good condition, with an ECOG score ranging from 0 to 1; 8. The patient is willing to receive intraperitoneal chemotherapy port placed through laparoscopy or open surgery within 28 days before the first study of medication and is willing to undergo intraperitoneal chemotherapy; 9. Expected survival period >= 6 months; 10. Laboratory test values within 7 days before enrollment must meet the following standards: (1) WBC > 4.0 x 10^9/L and 1.5 x 10^9/L, Hb >= 80 g/L, PLT >= 100 x 10^9/L; (2) Serum bilirubin 60 ml/min, based on the predicted glomerular filtration rate by Cockcroft-Gault: (140 - age) x (weight, kg) x (0.85, if female) / [72 x (Serum creatinine, mg/dL)] Or: (140 - age) x (weight, kg) x (0.85, if female) / [0.818 x (Serum creatinine, umol/L)]; (4) INR and aPTT <= 1.5 x ULN, only applicable to subjects who have not received anticoagulation therapy; subjects receiving anticoagulant therapy should be given a stable dose; 11. Good compliance, capable of cooperating with the laboratory, auxiliary examinations and corresponding specimen collection of this plan; 12. Fertile women (including those who have experienced menopause due to chemopenmenopause or other medical reasons) must agree to take contraceptive measures for at least five months (whichever is later) from the time of signing the informed consent form until the last administration of the study treatment or accompanying chemotherapy. Women must also agree not to breastfeed for at least five months (preferably later) from the signing of the informed consent form to the last administration of the study drug or accompanying chemotherapy. Men must agree to take contraceptive measures for at least 7 months (whichever is later) from the administration of the investigational drug to the administration of the investigational drug or in conjunction with chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to a component of the test drug; 2. Previous or current concurrent cancer with another malignancy (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer without recurrence for at least 5 years); 3. Absence of resolution to CTCAE grade 0-1 within 7 days before the first dose of study medication: (1) Acute or chronic pancreatitis; (2) Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection; (3) Diarrhea; (4) Intestinal obstruction, gastrointestinal perforation, gastrointestinal bleeding or high risk of bleeding; (5) Difficulty breathing; 4. Unable to take oral medication; 5. NYHA grade 3 or 4; 6. Symptoms and signs of related cardiovascular diseases, including myocardial infarction, congestive heart failure, arrhythmia, etc.; 7. Known cerebrovascular events; 8. The history of chemotherapy or radiotherapy within 30 days before the first study medication; 9. Use of anti-HER2, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 (or any other antibody acting on T cell costimulation or checkpoint pathway), Claudin18.2 monoclonal antibody, or tyrosine kinase inhibitor within 30 days before the first study dose; 10. Have comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (prednisone or other therapeutic hormones at a dose > 10 mg/day); 11. Received any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment; 12. Uncontrolled systemic diseases such as diabetes and hypertension; 13. Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; vitiligo or complete remission of asthma in childhood without any intervention in adulthood; patients with asthma requiring medical intervention with bronchodilators were excluded); 14. Subjects with active pulmonary tuberculosis (TB) who were receiving anti-TB treatment or had received anti-TB treatment within 1 year before screening; 15. A history of the following lung diseases as confirmed by imaging (preferably CT) or clinical findings: interstitial pneumonia, noninfectious pneumonia, pulmonary fibrosis, acute lung disease; 16. Pregnant or lactating women or those who may become pregnant; 17. A positive test for any of the following: antibody to human immunodeficiency virus-1 (HIV-1), antibody to human immunodeficiency virus-2 (HIV-2), antibody to human T-lymphotropic virus-1 (HTLV-1), antibody to hepatitis C virus (HCV); 18. Any other clinically significant disease or condition considered by the investigator to affect adherence to the protocol, or to affect the signing of the Informed Consent Form (ICF), or to preclude participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse events TEAE/SAE during treatment;Safety: the incidence and severity of adverse events, clinically significant abnormal laboratory test results; Surgical complications within 30 days after surgery;Progression-free survival;R0 resection rate of conversion surgery after treatment;Quality of life: EORTC QLQ-C30 (version 3), EORTC QLQ-STO22, EQ-5D-5L questionnaire;Objective Response Rate (ORR);Emotional scale: PHQ-9, GAD-7 emotional scale; | — |
Countries
China
Contacts
Public ContactLi Yuanfang
Sun Yat-sen University Cancer Center
Outcome results
None listed