In this study, the investigators will use Tislelizumab combined with LM-302 and S-1 versus Tislelizumab combined with SOX to treat Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Tislelizumab 200mg and LM-302 2.0mg/kg intravenous (IV) infusion on day 1 plus oral S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.
Tislelizumab 200mg and oxaliplatin 130 mg/m2 intravenous (IV) infusion on day 1 plus oral S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Huangpu District, China
RECRUITINGPathological complete response (pCR) rate
pCR is defined as the absence of residual tumor based on evaluation of the resected stomach and lymph node specimen according to Becker remission criteria
Time frame: up to 24 months
treatment related adverse events
Time frame: up to 24 months
Major Pathological Response (MPR) rate
Defined as tumor specimens resected after neoadjuvant therapy with residual tumor cells ≤10%
Time frame: up to 24 months
R0 resection rate
R0 resection rate was defined as the proportion of patients with complete resection of the tumor and negative margins, i.e. no residual tumors
Time frame: up to 24 months
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from treatment initiation until the occurrence of any predefined event, including disease progression preventing planned surgery, local or distant recurrence, or death from any cause
Time frame: up to 36 months
Overall survival (OS)
Overall survival (OS) is defined as the period from the initial date of neoadjuvant therapy to the date of death due to any cause.
Time frame: up to 36 months
treatment related adverse events
It is defined according to the AJCC 8th edition ypN staging system, with the ypN0 rate and total number of positive lymph nodes in the two groups.
Time frame: up to 24 months
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