This is a randomized, non-comparative, open-label, two-arm phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab plus induction chemotherapy versus adebrelimab plus SHR-8086 in patients with dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants in both arms will receive neoadjuvant adebrelimab 1200mg intravenously on day 1 of a 21-day cycle for four cycles.
Participants assigned to arm 1 will receive neoadjuvant XELOX (capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1) for one cycle.
Participants assigned to arm 2 will receive SHR-8068 280 mg administered intravenously on day 1 for one cycle.
Curative-intent D2 radical gastrectomy is scheduled 4-6 weeks after completion of the fourth cycle.
Pathological complete response (pCR) rate
The proportion of participants in whom no viable tumor cells remain in the primary tumor bed and regional lymph nodes (ypT0N0).
Time frame: From randomization to the date of surgery, an average of 14 weeks.
Major pathological response (MPR) rate
The proportion of participants in whom residual viable tumor cells constitute \<10 % of the primary tumor bed in the resected surgical specimen.
Time frame: From randomization to the date of surgery, an average of 14 weeks.
ypN stage
Lymph-node status after neoadjuvant therapy (ypN stage) will be assessed according to the American Joint Committee on Cancer (AJCC) 8th edition staging system.
Time frame: From randomization to the date of surgery, an average of 14 weeks.
R0 resection rate
The proportion of patients who undergo surgery with microscopically negative resection margins.
Time frame: From randomization to the date of surgery, an average of 14 weeks.
Event-free survival (EFS)
Time frame: The time from randomization to documented disease progression, disease recurrence, or death from any cause, whichever occurs first, assessed up to 5 years.
Overall survival (OS)
Time frame: The time from randomization to death from any cause, assessed up to 5 years.
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