Actively Recruiting
A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-05-07
49
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical study is to determine the efficacy and safety of the liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors among children, adolescents, and young adults. The key questions it intends to address are: Can the liposomal mitoxantrone combination regimen improve the objective response rate (ORR) compared to historical data? What are the adverse events associated with this combination regimen? Researchers will administer the liposomal mitoxantrone combination regimen (including capecitabine and anlotinib with specific dosing regimens) to the participants and closely monitor their conditions. Participants will: Receive the treatment regimen for 4 - 6 cycles, with each cycle lasting 21 days Undergo regular checkups and tests during the treatment period and follow-up period as per the protocol. Have their tumor status, blood parameters, and other relevant indicators measured to evaluate the treatment effect and safety.
CONDITIONS
Official Title
A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient fully understands the study, voluntarily participates, and signs informed consent.
- Aged between 6 and 24 years with expected survival time over 3 months.
- Diagnosed by histopathology with relapsed or refractory solid tumors including bone and soft tissue tumors, neuroblastoma, or other eligible solid tumors.
- Measurable tumor lesions visible by CT, enhanced CT, PET/CT, or MRI.
- Karnofsky score greater than 50; ECOG score 2 or less.
- Bone marrow function with neutrophil count over 1.5 × 10⁹/L, platelet count over 75 × 10⁹/L, and hemoglobin at least 80 g/L.
- Liver and kidney function within specified limits: serum creatinine no more than 1.5 times normal; AST and ALT less than 2.5 times normal (or less than 5 times normal if liver invaded); total bilirubin less than 1.5 times normal (or less than 3 times normal if liver invaded).
- No recent serious heart conditions or abnormal electrocardiogram findings within 6 months before enrollment.
You will not qualify if you...
- Known hypersensitivity to any study drug components.
- Uncontrolled other malignant tumors (except certain effectively controlled skin and in-situ cancers).
- Pregnant or breastfeeding women, or women of childbearing age unwilling to use contraception.
- Any other condition deemed unsuitable for participation by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
Sidan Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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