SOX regimen, consisting of oral S-1 and intravenous oxaliplatin, is the preferred regimen for perioperative chemotherapy for gastric cancer. The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion, as neoadjuvant chemotherapy, and conventional SOX regimen, in locally advanced gastric cancer. The main question it aims to answer is: whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer. Participants will be randomised, and receive: * 3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody, as neoadjuvant chemotherapy; * Adequate gastric resection along with D2 lymph node dissection; * 3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody. * Administration of S-1 regularly till 1 year after surgery. Researchers will compare Major pathological response rate (MPR) ,pathologic complete response rate(pCR),the 2-year overall survival (OS) rates, 2-year disease free survival (DFS), R0 resection rates, and adverse events, to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
3 cycles of SOX neoadjuvant chemotherapy every 21 days.
3 cycles of neoadjuvant immunotherapy every 21 days.
All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.
3 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.
3 cycles of adjuvant immunotherapy every 21 days.
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGMajor Pathological Response rate
The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.
Time frame: 6 months
R0 resection rate
The proportion of patients with margin-free resection
Time frame: 6 months
2-year Disease Free Rate
The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment
Time frame: 2 years
2-year Overall Survival Rate
The percentage of individuals in this study who are alive two years after their diagnosis or the start of treatment.
Time frame: 2 years
pathological Complete Response rate
The percentage of people with complete disappearance of all invasive carcinoma cells.
Time frame: 6 months
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