HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

Launched by SICHUAN UNIVERSITY · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced gastric cancer that has spread to the lining of the abdomen, known as peritoneal metastasis. Researchers want to see if combining a method called Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with standard chemotherapy and an immunotherapy drug called sintilimab can improve treatment outcomes. HIPEC involves delivering heated chemotherapy directly into the abdominal cavity, which may help the drugs work better against the cancer.

To participate in this trial, patients must be between 18 and 75 years old, have a specific type of stomach cancer that cannot be surgically removed, and have not received any previous cancer treatments. Participants will need to provide blood and tissue samples and should expect to be monitored closely for safety and treatment effectiveness. It’s important to note that this trial is not yet recruiting participants, so those interested will need to wait for it to start. Overall, this trial aims to find a more effective treatment for a challenging condition that currently has limited options.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years.
• • 2. Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological or cytological examination;
• • 3. No previous antitumor treatment.
• • 4. Agree to provide blood/tissue specimens.
• • 5. The expected survival is more than 3 months.
• • 6. ECOG PS≤1.
• 7. Adequate organ function including the following:
• • 1. Total bilirubin ≤1.5 times the upper limit of normal (ULN);
• • 2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
• • 3. Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
• • 4. Serum creatinine≤1.5×ULN;
• • 5. Serum amylase and lipase≤1.5×ULN;
• • 6. International standardized ratio (INR)/partial thromboplastin time (PTT)≤1.5×ULN;
• • 7. Platelet count ≥ 75,000 /mm3;
• • 8. Hemoglobin (Hb) ≥ 9 g/dL;
• • 9. Absolute neutrophil count (ANC) ≥ 1500/mm3;
• • 8. Strict contraception.
• • 9. Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
• Exclusion Criteria:
• • 1. Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
• • 2. Active autoimmune disease or history of refractory autoimmune disease.
• • 3. Receiving corticosteroids (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
• 4. Active or clinically significant cardiac disease:
• • 1. Congestive heart failure \> New York Heart Association (NYHA) class 2;
• • 2. Active coronary artery disease;
• • 3. Arrhythmias requiring treatment other than β-blockers or digoxin;
• • 4. Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
• • 5. Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6 months prior to enrollment;
• • 6. Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
• • 7. Patients with pheochromocytoma.
• • 8. Patients with a history of HIV infection or active hepatitis B/C.
• • 9. Ongoing \> level 2 infection.
• • 10. Symptomatic brain metastasis or meningioma.
• • 11. Unhealed wounds, ulcers or fractures.
• • 12. Renal failure patients requiring blood or peritoneal dialysis.
• • 13. Epileptic that needs medication.
• • 14. History of organ transplantation (including corneal transplantation).
• • 15. Allergic to research drugs or similar drugs, or suspected allergies.
• • 16. Pregnant or lactating women.
• • 17. Medical, psychological or social conditions can affect the recruitment of patients and evaluation of study results.
• • 18. Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed.
• • 19. Previously used similar chemotherapy drugs or immune checkpoint inhibitors;
• • 20. Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery (excluding biliary stents, or percutaneous biliary drainage).
• • 21. Treatment with antitumor Chinese herbal medicine.
• • 22. Vaccination history 4 weeks prior to enrollment
• • 23. The investigator believes that patients who are not suitable for the study.