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

Neoadjuvant Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459921
• Other study ID #: loong-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Xijing Hospital
• Contact: Jipeng Li, Doctor
• Phone: 13991316190
• Email: jipeng1974[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Gastric Cancer
• Neoadjuvant Chemotherapy
• Sintilimab
• Stomach Neoplasms

Intervention

Drug:
• SOX+Sintilimab
Patients would be allocated to the SOX+Sintilimab group.
• FLOT+Sintilimab
Patients would be allocated to the FLOT+Sintilimab group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of radical (R0) resection after neoadjuvant therapy	efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer.	From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
Secondary	adverse event	adverse event caused by FLOT, SOX or Sintilimab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events	From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
Secondary	disease-free survival	from diagnosis to recurrence or death	From date of diagnosis until the first documented recurrence or death, assessed up to 60 months