Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

Launched by XIJING HOSPITAL · Jun 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different treatment combinations for patients with locally advanced gastric cancer, which is a type of stomach cancer that has spread but is still contained in the area around the stomach. The researchers want to compare the results of patients receiving a combination of Sintilimab (an immunotherapy drug) with FLOT (a type of chemotherapy) versus those receiving Sintilimab with SOX (another chemotherapy combination). The goal is to see which treatment helps patients live longer without their disease coming back and allows for successful surgical removal of the cancer.

To participate in this trial, patients need to be at least 18 years old and have locally advanced gastric cancer that can potentially be treated with surgery after chemotherapy. They should also have a good overall health status (ECOG PS score of 0-1, meaning they are mostly active and not too affected by their illness). However, certain patients will not be eligible, such as those with metastatic cancer (cancer that has spread far from the stomach) or those who have had other cancer treatments recently. If eligible, participants can expect to receive the assigned treatment and regular follow-ups to monitor their health and response to the therapy. This trial is not currently recruiting patients but aims to provide valuable insights into better treatment options for gastric cancer in the future.

Gender

ALL

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.