Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04984018
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chidamide Plus Camrelizumab as Second-line Therapy for Advanced ESCC Treated With PD-1 Blockade
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: