Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer
NCT Number: NCT06510010
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chemotherapy Effect
Interventions: DRUG: Oxaliplatin With S-1 (SOX) Combined H. Pylori Eradication (Amoxicillin + clarithromycin + omeprazole + colloidal bismuth subcitrate)|DRUG: Oxaliplatin With S-1 （SOX）
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 198
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-07-31

Summary:
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.

Primary Outcome Measures: major 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%), Through postoperative pathology, an average of 2 week
Secondary Outcome Measures: pathological complete response (pCR), pCR defined as tumor regression grade (TRG) score of 0；TRG 0 represents complete remission (no residual cancer cells), 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., 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)., 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., 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., 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., Through postoperative pathology, an average of 2 week