A Phase 2 interventional study of Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine and Temozolomide+Irinotecan+Vincristine in Soft Tissue Sarcoma, sponsored by Yizhuo Zhang. Recruiting at 1 site in China. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Yizhuo Zhang · Phase 2, Interventional, and Treatment
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 110 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Yizhuo Zhang is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Mitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine.
Drug: Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine
Temozolomide combined with Irinotecan and Vincristine.
Drug: Temozolomide+Irinotecan+Vincristine
Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles.
Q3W, 4 cycles
Objective 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
Circulating tumor DNA (ctDNA) .
ctDNA was dynamically monitored and the correlation between ctDNA and efficacy was evaluated.
Time frame: Assessed up to 24 moths.
Plan to share: No
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Yizhuo Zhang