In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 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.
LM-302 2.0 mg/kg, Cadonilimab 10mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 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
RECRUITING1-year survival rate
Time frame: up to 24 months
treatment related adverse events
Time frame: up to 24 months
Progressive free survival (PFS)
Progression-free survival (PFS) is defined as the time from enrollemnt to disease progression or death from any cause.
Time frame: up to 36 months
Overall survival (OS)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 24 months
Objective response rate (ORR)
ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1 criteria.
Time frame: up to 24 months
Major Pathological Response (MPR) rate
Defined as tumor specimens resected after conversion surgery with residual tumor cells ≤10%
Time frame: up to 24 months
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