Combining SOX and FLOT chemotherapy with PD-1 antibody for advanced gastric cancer

Safety and Efficacy of Preoperative Adjuvant SOX Regimen Combined With PD-1 Antibody Versus FLOT Regimen With PD-1 Antibody for the Treatment of Localized Deficient Mismatch Repair Gastric Cancer: a Chinese Trial

This study tests whether combining two different chemotherapy treatments with a PD-1 antibody can help people with advanced gastric cancer shrink their tumors before surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Xi'an, Shaanxi and 2 other locations)
• Trial ID: NCT06440811 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of two preoperative chemotherapy regimens, SOX combined with a PD-1 antibody and FLOT combined with a PD-1 antibody, in patients with locally advanced gastric cancer that has deficient mismatch repair (dMMR). Participants will be divided into two groups to compare tumor regression, adverse effects, and disease-free survival between the two treatment approaches. The study focuses on understanding which regimen provides better outcomes for patients before surgical intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 100 diagnosed with locally advanced gastric cancer and identified as having deficient mismatch repair.

Not a fit: Patients with metastatic gastric cancer or those who have previously received anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with locally advanced dMMR gastric cancer.

How similar studies have performed: While the combination of chemotherapy and PD-1 antibodies is being explored in various contexts, this specific approach for dMMR gastric cancer is relatively novel and has not been extensively tested.

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.

Where this trial is running

Xi'an, Shaanxi and 2 other locations

• Tangdu hospital — Xi'an, Shaanxi, China (Active_not_recruiting)
• Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (Recruiting)
• Xijing hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Jipeng Li, Doctor — Xijing Hospital
• Study coordinator: Jipeng Li, Doctor

Conditions Gastric Cancer; Immune-related Adverse Event; Chemotherapeutic Toxicity; neoadjuvant chemotherapy; Nivolumab; SOX; FLOT; deficient Mismatch Repair