Gastric or gastro-esophageal junction adenocarcinoma
Conditions
Interventions
SOX + Sintilimab Group (Group A):Subjects will receive 6 cycles of systemic therapy with SOX + Sintilimab, followed by assessment for conversion surgery, and subsequent maintenance therapy with S-1 +
SOX + Sintilimab + Intraperitoneal Nab-paclitaxel Chemotherapy Group (Group B):Subjects will receive 6 cycles of systemic therapy with SOX + Sintilimab combined with intraperitoneal nab-paclitaxel che
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understands this study and voluntarily signs the informed consent form (ICF); 2. Newly diagnosed, untreated histologically confirmed gastric or gastroesophageal junction adenocarcinoma, with peritoneal metastasis confirmed by laparoscopy (positive cytology in ascites or pathologically positive peritoneal nodules), clinical stage IV; 3. According to RECIST (V1.1) criteria, there are measurable or non-measurable lesions. Except for regional lymph node metastases, only one single unresectable metastatic organ is allowed: (1) 1-2 liver metastases measuring 1-3 cm; (2) Para-aortic a2/b1 metastases; (3) Ovarian metastases; 4. Immunohistochemistry shows HER2 (0), HER2 (1+), or HER2 (2+) with negative FISH test; 5. Agrees to provide previously stored tumor tissue specimens or undergo biopsy to collect tumor tissue to be sent to the central laboratory for HER2, PD-L1, EBV, MSI IHC testing; 6. No gender restriction, aged 18-75 years; 7. General condition, ECOG score of 0-1 points; 8. Patients are willing to undergo laparoscopic or open surgical placement of peritoneal chemotherapy within 28 days before the first study drug administration, and are willing to receive intraperitoneal chemotherapy; 9. Expected survival >=6 months; 10. Laboratory checks within 7 days prior to enrollment must meet the following criteria: (1) WBC > 4.0×10^9/L and 1.5×10^9/L, Hb >= 80g/L, PLT >= 100×10^9/L; (2) Serum bilirubin 60 ml/min, estimated according to Cockcroft-Gault glomerular filtration rate: (140 - age) × (weight, kg) × (0.85, if female) / 72 × (serum creatinine, mg/dL) or: (140 - age) × (weight, kg) × (0.85, if female) / 0.818 × (serum creatinine, mg/dL) (4) INR and aPTT <= 1.5 × ULN only for subjects who are not receiving anticoagulation therapy; Subjects receiving anticoagulation therapy should be on a stable dose; 11. Good compliance, can cooperate with the laboratory, auxiliary examination and corresponding specimen collection of this plan; 12. Women of childbearing potential (including women who have gone through menopause due to chemical menopause or other medical reasons) must agree to use contraception from the signing of informed consent until at least 5 months after the last dose of study treatment or concomitant chemotherapy, whichever is later. Females must also agree not to breastfeed from signing informed consent until at least 5 months after the last dose of study drug or concomitant chemotherapy, whichever is later; Men must agree to use contraception from trial drug administration until at least 7 months after trial drug or concomitant chemotherapy administration, whichever is later.
Exclusion criteria
Exclusion criteria: 1. Known allergic reaction to any component of the investigational drugs. 2. History of or concurrent other malignancy, except for completely resected basal cell carcinoma, Stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer that has not recurred for at least 5 years. 3. Failure of the following diseases to resolve to CTCAE grade 0-1 within 7 days prior to the first study drug administration: (1)Acute or chronic pancreatitis; (2)Uncontrolled acute or chronic infection, e.g., pneumonia, biliary infection, hepatitis B virus infection, hepatitis C virus infection, etc.; (3)Diarrhea; (4)Intestinal obstruction, gastrointestinal perforation, gastrointestinal bleeding, or high risk of bleeding; (5)Dyspnea. 4. Inability to take oral medications. 5. NYHA functional class 3 or 4. 6. Symptoms and signs of relevant cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc. 7. Known history of cerebrovascular accident. 8. History of chemotherapy, radiotherapy, etc., within 30 days prior to the first study drug administration. 9. Use of anti-HER2 agents, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibody acting on T cell co-stimulation or checkpoint pathways), Claudin18.2 monoclonal antibody, tyrosine kinase inhibitors, or similar drugs within 30 days prior to the first study drug administration. 10. Comorbidities requiring long-term immunosuppressive therapy or systemic/topical use of corticosteroids at immunosuppressive doses (>10mg/day prednisone or equivalent). 11. Administration of any anti-infective vaccine (e.g., influenza, varicella) within 4 weeks prior to enrollment. 12. Uncontrolled systemic diseases such as diabetes, hypertension, etc. 13. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; subjects with asthma requiring bronchodilator medical intervention are excluded). 14. Subjects with active tuberculosis (TB), currently receiving anti-TB treatment or having received anti-TB treatment within 1 year prior to screening. 15. History of the following pulmonary diseases confirmed by imaging (preferably CT) or clinical findings: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease. 16. Women who are pregnant, breastfeeding, or potentially pregnant. 17. Positive result for any of the following tests: human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, human T-lymphotropic virus-1 (HTLV-1) antibody, hepatitis C virus (HCV) antibody. 18. Any other clinically significant disease or condition that, in the investigator's judgment, may affect protocol compliance, the subject's ability to sign the informed consent form (ICF), or suitability for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);R0 Resection Rate After Conversion Surgery Following Treatment;Objective Response Rate (ORR);Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs);Safety;Quality of Life;Emotion-related scales; | — |
Countries
China
Contacts
Public ContactYuanfang Li; Huiyan Luo
Sun Yat-Sen University Cancer Center
Outcome results
None listed