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

NCT06459921 | Not Yet Recruiting Phase 2

• 1 other identifier: loong-201
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• adverse event

  From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days

• disease-free survival

  From date of diagnosis until the first documented recurrence or death, assessed up to 60 months

Study Arms (2)

FLOT+Sintilimab

ACTIVE COMPARATOR

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.

Drug: FLOT+Sintilimab

SOX+Sintilimab

EXPERIMENTAL

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.

Drug: SOX+Sintilimab

Interventions

SOX+Sintilimab DRUG

Patients would be allocated to the SOX+Sintilimab group.

SOX+Sintilimab

FLOT+Sintilimab DRUG

Patients would be allocated to the FLOT+Sintilimab group.

FLOT+Sintilimab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \>=18 years and \<100 years.
• \. Diagnosed with locally advanced gastric cancer.
• \. Eastern Cooperative Oncology Group ECOG PS score 0-1.
• \. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
• \. deficient mismatch repair identified by pathological detection.

You may not qualify if:

• \. Locally advanced unable to resect or metastatic tumors.
• \. Patients with recurrence of residual gastric cancer
• \. Patients refusing surgical resection after preoperative chemotherapy therapy.
• \. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
• \. Patients with confirmed allergy to the study drug and/or its excipients.
• \. Severe malnutrition and active autoimmune diseases.
• \. Pregnant or lactating women.
• \. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
• \. Patients with acute infections requiring antibiotic treatment.
• \. Patients with acute infections requiring antibiotic treatment.
• \. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
• \. Positive test result for hepatitis B or hepatitis C virus.
• \. Untreated central nervous system metastatic peripheral neuropathy (\>grade 1).
• \. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
• \. Patients who are not expected to achieve R0 resection.

Sponsors & Collaborators

• Xijing Hospital: lead

Central Study Contacts

Jipeng Li, Doctor

CONTACT

13991316190; jipeng1974@aliyun.com

Yihuan Qiao, Doctor

CONTACT

18682986362; yhqiao1995@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share