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On the evening of February 10, Junshi Biotech announced that its product toripalimab (trade name: Tuoyi®, product code: JS001) combined with standard chemotherapy is used as a treatment for gastric or esophagogastric junction adenocarcinoma after radical resection.
The Phase III clinical study of adjuvant therapy (hereinafter referred to as "JUPITER-15 study", NCT05180734) has completed the first patient dosing
.
The JUPITER-15 study is a randomized, double-blind, placebo-controlled, international multicenter Phase III clinical study conducted by Prof.
Ji Jiafu from Peking University Cancer Hospital, Prof.
Shen Lin from Peking University Cancer Hospital and Prof.
Li Guoxin from Nanfang Hospital of Southern Medical University Led the lead, aiming to evaluate the clinical efficacy and safety of toripalimab versus placebo combined with standard chemotherapy as postoperative adjuvant therapy for patients with gastric or esophagogastric junction adenocarcinoma after radical resection.
It plans to enroll 680 patients.
More than 60 research centers are involved
.
This is the first large-scale international multi-center Phase III clinical study of a PD-1 inhibitor independently developed in China for adjuvant therapy in the field of gastric cancer with high incidence in Chinese
Toripalimab is the first domestically-produced monoclonal antibody targeting PD-1 approved for marketing in China.