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

NCT ID: NCT06459921

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Neoadjuvant Chemotherapy; Sintilimab; Locally Advanced Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

FLOT+Sintilimab

Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous OXA 85 mg/m² intravenous TXT 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Sintilimab: 200 mg every 3 weeks.

Group Type: ACTIVE_COMPARATOR

FLOT+Sintilimab

Intervention Type: DRUG

Patients would be allocated to the FLOT+Sintilimab group.

SOX+Sintilimab

Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. Sintilimab: 200 mg every 3 weeks.

Group Type: EXPERIMENTAL

SOX+Sintilimab

Intervention Type: DRUG

Patients would be allocated to the SOX+Sintilimab group.

Interventions

SOX+Sintilimab

Patients would be allocated to the SOX+Sintilimab group.

Intervention Type: DRUG

FLOT+Sintilimab

Patients would be allocated to the FLOT+Sintilimab group.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jipeng Li, Doctor

Role: CONTACT

jipeng1974@aliyun.com

13991316190

Yihuan Qiao, Doctor

Role: CONTACT

yhqiao1995@126.com

18682986362

Other Identifiers

loong-201

Identifier Type: -

Identifier Source: org_study_id