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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
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.
OS
From date of treatment until the date of death from any cause
Time frame: up to 2 years
ORR
Defined as the proportion of patients with a documented complete response, partial response(CR+PR)
Time frame: up to 1 year
PFS
From date of treatment until the date of first documented progression or date of death from any cause
Time frame: up to 1 year
DOR
Refers to the time when the tumor is first evaluated as CR or PR until the first assessment is PD (Progressive Disease) or any cause of death.
Time frame: up to 1 year
DCR
Defined as the proportion of patients with a documented complete response, partial response and stable response(CR+PR+SD)
Time frame: up to 1 year
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