This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Tucidinostat: age≥18years, 30mg, po., biw, q4w; age≥10years,\<18years,0.5mg/kg, biw, q4w Apatinib: BSA≥1.2m\^2, 500mg, qd, q4w BSA\<1.2m\^2, 250mg, qd, q4w
6-month progression-free survival rate
The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment
Time frame: 6 months
Progression-free survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
Objective Response Rate(ORR)
Objective Response Rate(ORR)by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR)
Time frame: 2 years
Disease Control Rate (DCR)
the total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD)
Time frame: 2 years
Overall survival(OS)
Time from treatment until death from any cause
Time frame: 2 years
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