Zhang Tengfei, Cui Kang, Liu Xiaodan, Han Yikai, Li Lin, Xie Jinhui, Dong Xiangwen, Bao Yuhan, Ren Shengju, Lei Ziwen, Yu Pu, Zhao Huan, Du Yabing, Ma Wang
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China.
The First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, China.
Cancer Pathog Ther. 2025 Jan 3;3(4):346-352. doi: 10.1016/j.cpt.2024.12.003. eCollection 2025 Jul.
Esophageal cancer (EC) is the seventh most prevalent cancer and the sixth most common cause of cancer-related mortalities worldwide. Camrelizumab, a monoclonal antibody, has demonstrated moderate efficacy in esophageal squamous cell carcinoma (ESCC). , a probiotic bacterium, has a complementary effect in immunotherapy. This study aimed to evaluate the combination of camrelizumab and for advanced ESCC.
This single-arm, single-center, exploratory trial was conducted at the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. Eligible patients received 200 mg camrelizumab biweekly and two bags of twice daily. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were disease control rate (DCR), overall survival (OS), objective response rate (ORR), and adverse events (AEs).
From May 2020 to October 2022, ten patients with advanced ESCC who did not respond to first-line therapy were admitted. At the data cutoff date (August 9, 2023), the median follow-up duration was 12 months. Two of 10 (20%) achieved objective responses. The median survival was 7.5 months and the median OS was not reached. Grade 3 treatment-related AEs occurred in two of the 10 patients (20%). No serious treatment-related AEs or deaths occurred.
Camrelizumab combined with showed favorable anticancer activity and may be a viable second-line treatment for patients with ESCC.
ChiCTR2000032093, https://www.chictr.org.cn.
食管癌（EC）是全球第七大常见癌症，也是癌症相关死亡的第六大常见原因。卡瑞利珠单抗，一种单克隆抗体，在食管鳞状细胞癌（ESCC）中已显示出中等疗效。[具体益生菌名称未给出]，一种益生菌，在免疫治疗中具有互补作用。本研究旨在评估卡瑞利珠单抗与[具体益生菌名称未给出]联合用于晚期ESCC的疗效。
本单臂、单中心探索性试验在中国郑州的郑州大学第一附属医院进行。符合条件的患者每两周接受200mg卡瑞利珠单抗治疗，且每天两次服用两袋[具体益生菌名称未给出]。主要终点是无进展生存期（PFS），次要终点是疾病控制率（DCR）、总生存期（OS）、客观缓解率（ORR）和不良事件（AE）。
从2020年5月至2022年10月，收治了10例对一线治疗无反应的晚期ESCC患者。在数据截止日期（2023年8月9日），中位随访时间为12个月。10例患者中有2例（20%）获得客观缓解。中位生存期为7.5个月，中位总生存期未达到。10例患者中有2例（20%）发生3级治疗相关不良事件。未发生严重的治疗相关不良事件或死亡。
卡瑞利珠单抗联合[具体益生菌名称未给出]显示出良好的抗癌活性，可能是ESCC患者可行的二线治疗方案。
ChiCTR2000032093，https://www.chictr.org.cn 。
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