Preoperative Adjuvant SOX Plus PL-1 Antibody and FLOT Plus PD-1 Antibody for Locally Advanced dMMR Gastric Cancer

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.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>=18 years and \<100 years.
• • 2. Diagnosed with locally advanced gastric cancer.
• • 3. Eastern Cooperative Oncology Group ECOG PS score 0-1.
• • 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
• • 5. deficient mismatch repair identified by pathological detection.
• Exclusion Criteria:
• • 1. Locally advanced unable to resect or metastatic tumors.
• • 2. Patients with recurrence of residual gastric cancer
• • 3. Patients refusing surgical resection after preoperative chemotherapy therapy.
• • 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. Patients with confirmed allergy to the study drug and/or its excipients.
• • 6. Severe malnutrition and active autoimmune diseases.
• • 7. Pregnant or lactating women.
• • 8. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
• • 9. Patients with acute infections requiring antibiotic treatment.
• • 10. Patients with acute infections requiring antibiotic treatment.
• • 11. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
• • 12. Positive test result for hepatitis B or hepatitis C virus.
• • 13. Untreated central nervous system metastatic peripheral neuropathy (\>grade 1).
• • 14. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
• • 15. Patients who are not expected to achieve R0 resection.
• • 16. Weight loss greater than or equal to 20% within 4 weeks before the first dose.
• • 17. Patients with multiple factors affecting oral medication.
• • 18. Vaccination within 4 weeks prior to the first dose of study drug.
• • 19. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
• • 20. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.

Trial Officials