This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.Tislelizumab: 200 mg administered concurrently with chemotherapy on days 1 and 22 via intravenous infusion, for a total of 3 cycles. Low Dose Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.
Chemotherapy: Oxaliplatin 130 mg/m² on days 1 and 22 plus capecitabine 1000 mg/m² twice daily on days 1-14, for a total of 3 cycles.
Radiotherapy: Initiated within one week after the start of chemotherapy; total dose (DT): 30 Gy.
Pathological Complete Response (pCR) Rate (ITT Population)
The pathological complete response (pCR) rate is defined as the proportion of patients in the intention-to-treat (ITT) population who achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.
Time frame: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.
Pathological Complete Response (pCR) Rate (Surgical Population)
The pathological complete response (pCR) rate in the surgical population is defined as the proportion of patients who undergo surgical resection and achieve pathological complete response after neoadjuvant treatment. Pathological complete response is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as determined by histopathological examination of the surgical specimens according to standardized pathological assessment criteria.
Time frame: At the time of surgery following completion of neoadjuvant therapy, based on pathological evaluation of the resected surgical specimen.
R0 Resection Rate
The R0 resection rate is defined as the proportion of patients who undergo surgical resection and achieve microscopically margin-negative resection (R0). R0 resection is defined as no residual tumor at the resection margins on histopathological examination of the surgical specimen, as assessed according to standard pathological criteria.
Time frame: At the time of surgery, based on pathological evaluation of the resected surgical specimen.
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization (or from treatment initiation in single-arm studies) to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence after surgery, or death from any cause. Patients who do not experience any of these events at the time of analysis will be censored at the date of the last disease assessment.
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Time frame: From the date of randomization until the occurrence of disease progression, recurrence, death, or end of follow-up, whichever occurs first, assessed up 60 months.
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last follow-up.
Time frame: From the date of randomization until death from any cause or end of follow-up, whichever occurs first, assessed up to 60 months.