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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Patients would be allocated to the SOX+Sintilimab group.
Patients would be allocated to the FLOT+Sintilimab group.
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.
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
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
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
disease-free survival
from diagnosis to recurrence or death
Time frame: From date of diagnosis until the first documented recurrence or death, assessed up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.