شركة Junshi Biologics تبدأ المرحلة الثانية من التجارب السريرية لJS212، والمؤشر هو سرطان المريء الحرشفي

药物临床试验登记与信息公示平台数据显示，上海君实生物医药科技股份有限公司的注射用JS212一项评价JS212联合治疗在晚期食管鳞癌患者中的安全性和有效性的开放、多中心II期临床研究已启动。
Clinical trial registration and information disclosure platform data show that Shanghai Junshi Biosciences Co., Ltd. has initiated an open, multicenter Phase II clinical study evaluating the safety and efficacy of JS212 in combination therapy for patients with advanced esophageal squamous cell carcinoma.

临床试验登记号为CTR20261087，首次公示信息日期为2026年3月26日。
The clinical trial registration number is CTR20261087, and the date of the first information disclosure is March 26, 2026.

该药物剂型为注射用无菌粉末，用法为静脉滴注给药，用量为每个周期第一天给予选定的剂量水平，用药时程为每3周一个周期，持续至方案规定的终止标准。
The drug form is sterile powder for injection, administered via intravenous drip, with a dose given on the first day of each cycle at a selected dose level, and the treatment schedule is one cycle every 3 weeks, continuing until the protocol-defined termination criteria are met.

本次试验主要目的为评价JS212联合用药在晚期食管鳞癌患者中的安全性和耐受性，确定JS212联合用药的最大耐受剂量及III期临床研究推荐剂量，评估JS212联合用药治疗晚期食管鳞癌患者的客观缓解率。
The main purpose of this trial is to evaluate the safety and tolerability of JS212 in combination therapy for patients with advanced esophageal squamous cell carcinoma, to determine the maximum tolerated dose of JS212 in combination therapy and the recommended dose for Phase III clinical studies, and to assess the objective response rate of JS212 combination therapy in treating advanced esophageal squamous cell carcinoma patients.

注射用JS212为生物制品，适应症为食管鳞癌。
JS212 for injection is a biological product indicated for esophageal squamous cell carcinoma.

食管鳞癌是食管癌主要亚型，起源于食管鳞状上皮，早期症状不明显，进展后出现吞咽困难等，诊断依赖内镜及病理检查，晚期患者预后较差。
Esophageal squamous cell carcinoma is the main subtype of esophageal cancer, originating from the squamous epithelium of the esophagus, with early symptoms being subtle, progressing to difficulties in swallowing, and diagnosis relying on endoscopy and pathology, with a poor prognosis for advanced-stage patients.

本次试验主要终点指标包括安全性和耐受性、最大耐受剂量、III期临床研究推荐剂量、客观缓解率；次要终点指标包括其他有效性指标、血药浓度特征、免疫原性。
The primary endpoints of this trial include safety and tolerability, maximum tolerated dose, recommended dose for Phase III clinical studies, and objective response rate; secondary endpoints include other efficacy indicators, pharmacokinetic characteristics, and immunogenicity.

目前，该试验状态为进行中（尚未招募），目标入组人数280人。
Currently, the status of the trial is ongoing (not yet recruiting), with a target enrollment of 280 participants.

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Disclaimer: The market carries risks, and investment should be cautious.

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