Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.
Children with relapsed/refractory soft tissue sarcoma who meet the inclusion criteria are randomly divided into VIM group and VIT group (irinotecan, vincristine, temozolomide) at 1:1. The efficacy and safety of the two groups are compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles.
Q3W, 4 cycles
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
Objective response rate (ORR) after 2 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)
Time frame: Up to 2 cycles of chemotherapy (each cycle is 21 days)
Objective response rate (ORR)
Objective response rate (ORR) after 4 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)
Time frame: Up to 4 cycles of chemotherapy (each cycle is 21 days)
Disease control rate (DCR)
Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy
Time frame: Up to 4 cycles of chemotherapy (each cycle is 21 days)
Progression-free survival (PFS)
Means from the date of enrollment to the date of first disease progression or death from any cause, whichever comes first. If the subject has no disease progression during the trial period, PFS is defined as the last date until the subject's last confirmed progression-free survival.
Time frame: From date of radomization unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 moths.
Overall survival (OS)
Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.
Time frame: From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths
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