Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial
Able to understand and agree to comply with study requirements and the assessment schedule, and voluntarily sign the written informed consent form (ICF) before any trial-related procedures are implemented;
Age greater than 18 years, regardless of gender. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease.
PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
1. Known HER2-positive expression (immunohistochemistry [IHC] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
Known central nervous system metastases and/or carcinomatous meningitis.
Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.