This study evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G/EGJ) adenocarcinoma who are PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
3yr-RFS rate
Defined as the proportion of patients who have not developed local or regional recurrence or distant metastasis from randomization to the 3-year follow-up, excluding second primary malignancies and non-tumor-related deaths.
Time frame: from randomization to the 3-year follow-up
Recurrence-Free Survival (RFS)
Defined as the time from randomization to the occurrence of local or regional recurrence or distant metastasis, excluding second primary malignancies and non-tumor-related deaths. If a patient does not experience disease progression during the study period, RFS is defined as the time to the last date on which the patient was confirmed to be progression-free.
Time frame: from randomization until the date of first documented occurrence of local or regional recurrence or distant metastasis, whichever came first,Up to 5 years
Overall Survival (OS)
Overall survival is defined as the time from patient enrollment to death from any cause. For patients who are still alive at the last follow-up, OS is censored at the date of last follow-up. For patients lost to follow-up, OS is censored at the last date on which the patient was confirmed to be alive prior to loss to follow-up. Censored OS is defined as the time from enrollment to censoring.
Time frame: From date of randomization until the date of first documented date of death from any cause,Up to 5 years.
Safety
All adverse events occurring in patients during the clinical study period will be monitored, including clinical symptoms, abnormal vital signs, and laboratory test abnormalities. The clinical characteristics, severity, time of onset, duration, management, and outcome of each adverse event will be recorded, and the causal relationship with the investigational drug will be assessed. Drug safety will be evaluated using the NCI-CTCAE Version 5.0 criteria.
Time frame: All subjects should continue to undergo safety assessments and adverse event follow-up for 90 days after the last dose, and concomitant treatments should be recorded.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.