Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma

Launched by XIJING HOSPITAL · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for patients with locally advanced gastric cancer that has a specific genetic marker called deficient mismatch repair (dMMR). The study aims to compare two different chemotherapy approaches combined with a type of immune therapy called PD-1 antibody: one group will receive the SOX regimen, while the other will receive the FLOT regimen. Researchers want to understand which treatment is safer and more effective before surgery, focusing on how well the tumors shrink, any side effects patients may experience, and how long patients remain free from the disease after treatment.

To participate in this trial, individuals must be at least 18 years old and have a diagnosis of locally advanced gastric cancer. They should be well enough to undergo surgery and have not received other cancer treatments recently. Participants can expect to undergo the assigned chemotherapy regimen along with PD-1 antibody therapy and be monitored closely for side effects and treatment outcomes. This study is currently recruiting, and it’s important for potential participants to discuss their eligibility with their healthcare provider to understand if they can take part in this important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histopathological confirmation of GC or GEJC.
• • 2. Absence of prior anti-tumor treatments, encompassing surgical resection, chemotherapy, radiotherapy, or immunotherapy.
• • 3. Age within the range of 18 to 75 years.
• • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
• • 5. Absence of concurrent malignancies.
• • 6. For patients with resectable GC, those with locally advanced stage III and IVA were clearly included according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system, and there were no unresectable factors.
• • 7. Patients with HER-2 negative.
• • 8. Basal information such as hematology and pathological histology was complete.
• Exclusion Criteria:
• • 1. Refusal of surgical resection subsequent to neoadjuvant therapy.
• • 2. Receipt of other ICIs during the study period.
• • 3. Receipt of corticosteroids during the study period.
• • 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
• • 5. Confirmed recurrence of GC.
• • 6. Hypersensitivity to the study medication.
• • 7. Systemic medical conditions contraindicating chemotherapy.
• • 8. Psychiatric illnesses contraindicating chemotherapy.
• • 9. Acute infections necessitating antibiotic therapy.
• • 10. Uncontrolled diabetes mellitus.
• • 11. Metastatic disease.
• • 12. Severe malnutrition.
• • 13. Active autoimmune disorders.
• • 14. Pregnancy or lactation.
• • 15. Positive serological test for hepatitis B or C virus infection,
• • 16. Untreated central nervous system metastases peripheral neuropathy.
• • 17. Severe myelosuppression.
• • 18. Severe hepatic or renal insufficiency (Child-Pugh C, estimated glomerular filtration rate \[eGFR\] \<30 mL/min).
• • 19. Significant cardiac history.
• • 20. Patients with a history of allogeneic organ transplantation.
• • 21. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
• • 22. Patients with multiple factors affecting oral medication.
• • 23. Vaccination within 4 weeks prior to the first dose of study drug.
• • 24. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
• • 25. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.