camrelizumab联合副卡西乳酸菌治疗晚期食管鳞状细胞癌的疗效和安全性：单臂、单中心、探索性试验

IF 2.8

Cancer pathogenesis and therapy Pub Date : 2025-07-01 DOI:10.1016/j.cpt.2024.12.003

Tengfei Zhang , Kang Cui , Xiaodan Liu , Yikai Han , Lin Li , Jinhui Xie , Xiangwen Dong , Yuhan Bao , Shengju Ren , Ziwen Lei , Pu Yu , Huan Zhao , Yabing Du , Wang Ma

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引用次数: 0

摘要

食管癌（EC）是全球第七大常见癌症和第六大癌症相关死亡原因。Camrelizumab是一种单克隆抗体，已证明对食管鳞状细胞癌（ESCC）有中等疗效。副干酪乳杆菌是一种益生菌，在免疫治疗中具有互补作用。本研究旨在评估camrelizumab与副乳杆菌（L. paracasei）联合治疗晚期ESCC。方法单臂、单中心、探索性试验在郑州大学第一附属医院进行。符合条件的患者每两周接受200 mg camrelizumab治疗，每天两次接受2袋副干酪乳杆菌治疗。主要终点为无进展生存期（PFS），次要终点为疾病控制率（DCR）、总生存期（OS）、客观缓解率（ORR）和不良事件（ae）。结果2020年5月至2022年10月，10例对一线治疗无效的晚期ESCC患者入院。在数据截止日期（2023年8月9日），中位随访时间为12个月。2 / 10（20%）达到客观反应。中位生存期为7.5个月，中位OS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反应或死亡。结论scamrelizumab联合副乳杆菌（L. paracasei）具有良好的抗癌活性，可能是ESCC患者可行的二线治疗方案。试验注册chictr2000032093， https://www.chictr.org.cn。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial

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Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial

Background

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). Lactobacillus paracasei, a probiotic bacterium, has a complementary effect in immunotherapy. This study aimed to evaluate the combination of camrelizumab and L. paracasei for advanced ESCC.

Methods

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 L. paracasei 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).

Results

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.