This is a phase 2 study designed to evaluate the safety and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) in perioprative treatment of locally advanced MHC-II-negative gastric and gastroesophageal junction adenocarcinoma.
Patients voluntarily enrolled in this study and signed informed consent forms;
Age 18-75 years;
Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
MHC-II negative, with <5% tumour cells displaying staining <2+ (grade 2 or stronger);
Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational medicinal product.
Known signs of active bleeding from a lesion.
Patients with known dMMR/MSI-H status.
Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.
Single group
IBI363 + chemotherapy
DrugIBI363 Q3W +XELOX Q3W (Oxaliplatin 130 mg/m2, IV, Q3W, Capecitabine ,1000mg/ m2, PO, Bid, d1-14, Q3W) or IBI363 Q3W +SOX (Oxaliplatin 130 mg/m2, IV, Q3W, S-1, 40-60mg,PO, Bid, d1-14，Q3W )
Pathological Complete Response (pCR) rate of ITT population
The proportion of subjects in the cohort defined as having no residual tumour cells detected microscopically and lymph node-negative following neoadjuvant therapy.
Pathological Complete Response (pCR) Rate or surgical population
The proportion of subjects undergoingvradical surgery who, following neoadjuvant therapy, were found to have no residual tumour cells under microscopic examination and negative lymph nodes.
Major Pathologic Response (MPR) Rate of ITT Population
The proportion of subjects in the enrolled population who achieved pathological residual tumour ≤10% as defined by tumour regression induced by neoadjuvant therapy.
Major Pathologic Response (MPR) Rate of surgical population
The proportion of subjects undergoing radical surgery who achieved pathological residual tumour ≤10% following neoadjuvant therapy-induced tumour regression.
R0 Resection Rate
The proportion of subjects defined as having undergone R0 resection within the radical resection population.
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