Gastric cancer, peritoneal metastasis
Conditions
Interventions
Experimental group:Paclitaxel (albumin-bound type) intraperitoneal perfusion for injection combined with intravenous sindilimab-SOX
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be over 18 years of age at the time of signing the informed consent or be able to exercise informed consent in accordance with local laws. 2. Gastric adenocarcinoma was confirmed histologically or cytologically. 3. There were evaluable or non-evaluable lesions according to RECIST(V1.1) criteria. Except lymph node metastasis, only one substantial organ was involved in metastasis. 4. Diagnosis of gastric cancer with peritoneal metastasis (positive imaging findings or cytology of ascites/abdominal effusion). 5. The standard systemic antitumor regimen for gastric cancer was not received prior to initiation of the first study. 6. Palliative gastrectomy or exploratory laparotomy was performed within 28 days before the initiation of the first study. 7. Subject s were willing to be placed in an abdominal chemotherapy port by laparoscopy or open surgery within 28 days before the initial study. 8. The subject is willing to undergo abdominal chemotherapy. 9. Expected survival >=6 months. 10. The activity status of the Eastern Cancer Collaboration Group (ECOG) was 0 or 1. 11. Laboratory tests are required to meet the following criteria: (1) Hematology: ANC(absolute neutrophil count)>=1.5x10^9/L; Hemoglobin >=80g/L; Platelet >=100x10^9/L; (2) Liver function: serum bilirubin =30 ml /min. 12. The use of contraceptive pills by male and female subjects shall comply with local regulations on contraceptive methods for persons participating in clinical studies: (1) Male subjects: use medically approved contraceptive methods for contraception from the screening period to 30 days after the last study dose; (2) Female subjects: use a medically approved contraceptive method for at least 1 month prior to screening and consent to use this method for contraception from the screening period until 30 days after the final study dose. 13. Ability to sign informed consent as described in Appendix 1, including compliance with the Informed Consent (ICF) and the requirements and restrictions outlined in this protocol.
Exclusion criteria
Exclusion criteria: 1. The following diseases have not resolved to CTCAE Grade 0-1 within 7 days before the first study: Uncontrolled acute and chronic infections, such as acute or chronic pancreatitis such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection; Diarrhea; Dyspnea. 2. NYHA rating 3 or 4. 3. Symptoms and signs of related cardiovascular diseases, including myocardial infarction, congestive heart failure, arrhythmia, etc. 4. Known cerebrovascular accidents. 5. Gastrointestinal and intestinal obstruction occurred within 30 days prior to initial administration. 6. Imaging diagnosis of portal vein obstruction, including tumor compression, portal thrombus, cancer thrombus, etc. 7. History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autohemolytic anemia, rheumatoid arthritis, etc.). 8. Known HIV seropositivity, hepatitis C infection, and/or hepatitis B (Except for patients who are HepBsAg or core antibody positive and have responded to antiviral therapy for hepatitis B: these patients were admitted to this study; Remarks: Patients with HepBsAg negative at screening and subjects with HBV DNA below the lower limit of normal after treatment [LLN] are eligible to participate in this study). 9. A clear history of neurological or psychiatric disorders, including epilepsy or dementia. 10. Other serious systemic diseases that may limit patients' participation in the study (e.g. uncontrolled diabetes, cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, etc.). 11. Known or suspected allergy to the study drug. 12. Previous antitumor therapy, including chemotherapy, immunotherapy, biologics, hormone therapy, radiotherapy (except local radiotherapy for pain relief), etc., should be performed no more than 21 days after the date of the last treatment. 13. A history of abdominal infection. 14. Receive other antitumor investigational drugs within 30 days prior to initial investigational drug use. 15. Intracranial metastasis is known. 16. Pregnancy or breastfeeding during the study of drug treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Translational success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;R0 resection rate and safety;Three-year survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactXu Ruihua
Sun Yat-sen University Cancer Center
Outcome results
None listed