About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
SOX+Sintilimab
DrugPatients would be allocated to the SOX+Sintilimab group.
FLOT+Sintilimab
DrugPatients would be allocated to the FLOT+Sintilimab group.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
disease-free survival
from diagnosis to recurrence or death
Locations
Sponsors and contacts
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