This study focuses on patients with H. pylori-positive resectable locally advanced adenocarcinoma of the gastric and oesophagogastric junction. It evaluates the perioperative oxaliplatin with S-1 (SOX) combined H. pylori eradication versus oxaliplatin with S-1 in the management of H. pylori-positive locally advanced adenocarcinoma of the gastric and oesophagogastric junction (cT3/4a Nx or T2 N2/3, M0) , assessing their values and advantages.
Subjects randomized to the trial group will receive 3-4 cycles of oxaliplatin with S-1 (SOX)+ H. pylori eradication (a 14-day quadruple regimen: amoxicillin + clarithromycin + omeprazole + bismuth potassium citrate) before surgery. One of the SOX regimens will be every 3 weeks (Q3W), with a tumor response assessment at the end of the neoadjuvant therapy course. Patients will continue to receive 4-5 cycles of SOX adjuvant chemotherapy after surgery for a total of 8 cycles of SOX regimen treatment. Patients in the trial group will undergo H. pylori eradication at the time of the first cycle of the SOX regimen. H. pylori eradication will be determined by postoperative pathology, and those who are H. pylori-positive by postoperative pathology will be treated with remedial eradication therapy after recovery from surgery (except for patients with total gastric resection). Subjects randomized to the control group will receive 3-4 cycles of neoadjuvant therapy with the SOX regimen before surgery. The SOX regimen will be administered every 3 weeks (Q3W). A tumor response assessment will be performed at the end of the treatment course. Control patients were treated with H. pylori eradication after recovery from surgery based on postoperative pathologic H. pylori results: if H. pylori-positive, they received H. pylori eradication plus 4-5 cycles of SOX adjuvant chemotherapy (except for patients who underwent total gastric resection); if H. pylori-negative, they received 4-5 cycles of SOX adjuvant chemotherapy only. A formal interim analysis will schedule once 60 enrolled participants have completed the primary endpoint. This analysis will serve as the decisive basis for determining whether to terminate this study early. Criteria for early termination are as follows: (i) Efficacy-driven termination: If the analysis of the primary outcome across the 60 participants achieves statistical significance (p \< 0.05), indicating that the anticipated clinical trial objectives have been fully realized, patient enrollment will be discontinued immediately. (ii) Feasibility-driven termination: If the analysis fails to reach statistical significance, a scientific and feasibility assessment will be initiated to determine whether to prematurely halt or proceed with subsequent enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Oxaliplatin With S-1 (SOX) regimen: S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle. H. pylori eradication regimen: H. pylori eradication was performed using a quadruple regimen for 14 d. Omeprazole 20 mg bid+Colloidal bismuth subcitrate 220mg bid+Amoxicillin 1g bid+Clarithromycin 500mg bid.
Oxaliplatin With S-1 (SOX) regimen: S-1: 40mg/m2, oral, bid, D1-14, one cycle every 3 weeks; Oxaliplatin: 130 mg/m2, IV, qd, D1, every 3 weeks for one cycle.
The Sixth Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
RECRUITINGmajor pathological response (MPR)
MPR defined as a tumor regression grade (TRG) score of 0-1; TRG 0 represents complete remission (no residual cancer cells), TRG 1 meant significant remission (residual lesions \< 10%)
Time frame: Through postoperative pathology, an average of 2 week
pathological complete response (pCR)
pCR defined as tumor regression grade (TRG) score of 0;TRG 0 represents complete remission (no residual cancer cells)
Time frame: Through postoperative pathology, an average of 2 week
overall survival (OS)
Overall survival (OS) refers to the time from the beginning of randomization to death from any cause.
Time frame: From date of first administration until the date of death from any cause, assessed up to 36 months"
disease-free survival (DFS)
Disease-free survival (DFS) refers to the time from the beginning of randomization to the recurrence of the disease or death from any cause (whichever occurs first).
Time frame: From the date of first administration until the date of first disease recurrence or date of death from any cause, whichever came first, assessed up to 36 months.
adverse events (AE)
Adverse events (AE) means all adverse medical events that occur after the subject has received the experimental medication.
Time frame: From the beginning of the first neoadjuvant chemotherapy to 60 days after the last adjuvant chemotherapy
serious adverse events (SAE)
Serious adverse events (SAE) means an adverse medical event resulting in death, life-threatening, permanent or severe disability or loss of function, the need for or prolongation of hospitalization of the subject, and congenital anomalies or birth defects after the subject has received the experimental medication.
Time frame: From the beginning of the first neoadjuvant chemotherapy to 60 days after the last adjuvant chemotherapy
R0 resection rate
No cancer cells could be found at the cut edge of the specimen under the microscope, and no cancer cells remained either visually or microscopically; the lesion was completely removed.
Time frame: Through postoperative pathology, an average of 2 week
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