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...
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Elsevier
2025-07-01
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| Series: | Cancer Pathogenesis and Therapy |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949713224001058 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Tengfei Zhang |
| collection | DOAJ |
| description | 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. Conclusions: Camrelizumab combined with L. paracasei showed favorable anticancer activity and may be a viable second-line treatment for patients with ESCC. Trial registration: ChiCTR2000032093, https://www.chictr.org.cn. |
| format | Article |
| id | doaj-art-3dd5375bbb534e198ccefb3ba744a337 |
| institution | DOAJ |
| issn | 2949-7132 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Cancer Pathogenesis and Therapy |
| spelling | doaj-art-3dd5375bbb534e198ccefb3ba744a3372025-08-20T02:44:50ZengElsevierCancer Pathogenesis and Therapy2949-71322025-07-013434635210.1016/j.cpt.2024.12.003Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trialTengfei Zhang0Kang Cui1Xiaodan Liu2Yikai Han3Lin Li4Jinhui Xie5Xiangwen Dong6Yuhan Bao7Shengju Ren8Ziwen Lei9Pu Yu10Huan Zhao11Yabing Du12Wang Ma13Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaThe First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, ChinaThe First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, ChinaThe First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, ChinaThe First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, ChinaThe First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, ChinaThe First Clinical Medical School, Zhengzhou University, Zhengzhou, Henan 450000, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, ChinaDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China; Corresponding author: Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China.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. Conclusions: Camrelizumab combined with L. paracasei showed favorable anticancer activity and may be a viable second-line treatment for patients with ESCC. Trial registration: ChiCTR2000032093, https://www.chictr.org.cn.http://www.sciencedirect.com/science/article/pii/S2949713224001058CamrelizumabEsophageal squamous cell carcinomaLacticaseibacillus paracaseiImmunotherapy |
| spellingShingle | 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 Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial Cancer Pathogenesis and Therapy Camrelizumab Esophageal squamous cell carcinoma Lacticaseibacillus paracasei Immunotherapy |
| title | Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial |
| title_full | Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial |
| title_fullStr | Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial |
| title_full_unstemmed | Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial |
| title_short | Efficacy and safety of camrelizumab plus Lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma: A single-arm, single-center, exploratory trial |
| title_sort | efficacy and safety of camrelizumab plus lacticaseibacillus paracasei in the treatment of advanced esophageal squamous cell carcinoma a single arm single center exploratory trial |
| topic | Camrelizumab Esophageal squamous cell carcinoma Lacticaseibacillus paracasei Immunotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S2949713224001058 |
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