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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IBI363 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 )
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPathological 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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
R0 Resection Rate
The proportion of subjects defined as having undergone R0 resection within the radical resection population.
Time frame: Up to 3 years
Event-free Survival (EFS)
Defined as the time from randomization to the first occurrence of disease progression determined using RECIST v1.1, inoperable disease, local recurrence following surgery, distant metastasis, or death from any cause, whichever occurs first.
Time frame: Up to 3 years
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Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Time frame: Up to 3 years
AE
Number of participants experiencing clinical adverse events (AEs)
Time frame: Up to 90 days post last dose