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.
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
Age ≥ 18 years at registration;
Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;
Claudin 18.2 positive (≥ 25%, moderate to strong staining);
Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
Pregnant or breastfeeding women;
Prior treatment with Claudin 18.2 targeted therapy;
History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
Parallel
LM-302, S-1, paclitaxel
DrugLM-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, Cadonilimab, S-1, paclitaxel
DrugLM-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.
1-year survival rate
treatment related adverse events
Progressive free survival (PFS)
Progression-free survival (PFS) is defined as the time from enrollemnt to disease progression or death from any cause.
Overall survival (OS)
Disease control rate (DCR)
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