Trials / Recruiting
RecruitingNCT06514313
Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
Phase II Randomized Controlled Clinical Trial of Mitoxantrone Hydrochloride Liposome Combined With Irinotecan and Vincristine (VIM) With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Yizhuo Zhang · Academic / Other
- Sex
- All
- Age
- 2 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine | Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles. |
| DRUG | Temozolomide+Irinotecan+Vincristine | Q3W, 4 cycles |
Timeline
- Start date
- 2024-07-03
- Primary completion
- 2026-08-01
- Completion
- 2026-12-01
- First posted
- 2024-07-23
- Last updated
- 2024-07-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06514313. Inclusion in this directory is not an endorsement.