Efficacy and safety of camrelizumab plus 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). , a probiotic bacterium, has a complementary effect in immunotherapy. This study aimed to evaluate the combination of camrelizumab and 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 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 showed favorable anticancer activity and may be a viable second-line treatment for patients with ESCC.

TRIAL REGISTRATION

ChiCTR2000032093, https://www.chictr.org.cn.