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.
Eastern Cooperative Oncology Group(ECOG) score 0-1
Ambulatory males or females, aged 18-75 years
Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
Locally advanced gastric carcinoma (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)
Patients can not bear surgical procedure.
Pregnant or lactating women.
HER2 overexpression(+++) confirmed by immunohistochemistry.
Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
Parallel
Oxaliplatin by arterial infusion plus S-1
Drug3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
SOX neoadjuvant
Drug3 cycles of SOX neoadjuvant chemotherapy every 21 days.
Sintilimab neoadjuvant
Drug3 cycles of neoadjuvant immunotherapy every 21 days.
gastrectomy plus D2 lymph node dissection
Procedure/SurgeryAll patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.
SOX adjuvant, Sequential S-1
Drug3 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.
Sintilimab adjuvant
Drug3 cycles of adjuvant immunotherapy every 21 days.
Major Pathological Response rate
The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.
R0 resection rate
The proportion of patients with margin-free resection
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
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.
pathological Complete Response rate
The percentage of people with complete disappearance of all invasive carcinoma cells.
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