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
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.
CONDITIONS
Brief 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...
- Participants aged 6 to 24 years with expected survival over 3 months
- Confirmed diagnosis of relapsed and refractory solid tumors by histopathology
- Tumor subtypes include 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
- Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 75 x 10^9/L, hemoglobin ≥ 80 g/L
- Liver and kidney function within defined limits for creatinine, AST, ALT, and bilirubin
- No recent severe heart conditions or abnormal ECG within 6 months
- Ability to understand and voluntarily sign informed consent form
You will not qualify if you...
- Known hypersensitivity to any study drug components
- Uncontrolled other malignant tumors except certain effectively controlled cancers
- Pregnancy, lactation, or unwillingness to use contraception for women of childbearing age
- Any other conditions judged by investigators as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 cycles of 21 days each
Participants receive a combination regimen of liposomal mitoxantrone, capecitabine, and anlotinib in repeated 21-day cycles.
Repeated visits every 21 days for up to 6 cycles
Duration - Variable depending on local treatment schedule
Participants who achieve a partial response or better may undergo local treatment such as surgery or radiotherapy.
1 to 2 visits depending on local treatment requirements
Duration - Up to 1 year
Participants are monitored for safety and survival outcomes after treatment completion.
Periodic visits during follow-up for safety monitoring
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
Sidan Li
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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