NCT04984018

Chidamide Plus Camrelizumab as Second-line Therapy for Advanced ESCC Treated With PD-1 Blockade

An Single-arm Open-label Phase II Study of Chidamide Plus Camrelizumab as Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma Treated With PD-1 Blockade.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of chidamide plus camrelizumab as second-line therapy for advanced esophageal squamous cell carcinoma treated with PD-1 blockade

Detailed description

Although immune checkpoint inhibitors (ICIs) have been tested in esophageal squamous cell carcinoma(ESCC) with demonstrated clinical efficacy，a significant number of patients who have an initial response will develop a secondary resistance and relapse. recent studies on the role of epigenetics in immune evasion have exposed a key role for epigenetic modulators in augmenting the tumour microenvironment and restoring immune recognition and immunogenicity. These discoveries have established a highly promising basis for studies using combined epigenetic and immunotherapeutic agents as anti-cancer therapies. Chidamide is a novel orally active benzamide-type histone deacetylase inhibitor that has shown in vitro activities against a wide array of neoplasms. Hence, the study of chidamide plus camrelizumab as second-line therapy for advanced ESCC treated with PD-1 blockade was performed.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	chidamide + camrelizumab	Pts received 200 mg camrelizumab intravenously every 2 weeks and Chidamide 30mg orally twice (biw) per week for 4 consecutive weeks every 6 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-07-30
• Last updated: 2021-07-30