Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors
Chidamide,a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
objective response rate(ORR)
the total proportion of patients with complete response(CR)and partial response(PR)
Time frame: up to 2 years
Disease Control Rate (DCR)
the total proportion of patients with complete response(CR), partial response(PR)and Stable Disease(SD)
Time frame: up to 2 years
Duration of Response (DOR)
Time from first documented complete response (CR) or partial response (PR) until time of progression.
Time frame: up to 2 years
progression-free survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
overall survival(OS)
Time from treatment until death from any cause
Time frame: 2 years
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