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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
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
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.
Key Details
Gender
All
Age Range
6 Years - 24 Years
Study Type
INTERVENTIONAL
Enrollment
49
Start Date
2025-02-01
Completion Date
2028-02-01
Last Updated
2025-01-08
Healthy Volunteers
No
Conditions
Interventions
Mitoxantrone liposome
Mitoxantrone liposome: 16 mg/m\^2, d1; Each 21-day cycle was used for a total of 4-6 cycles.
Capecitabine
Capecitabine 1000 mg/m\^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles.
Anlotinib
Anlotinib: according to patient weight: 8mg/ day in patients \<35kg; 10mg/ day for patients with 35kg≤ patient weight ≤50kg; 12mg/ day for patients \> 50kg; d1-14; Each 21-day cycle was used for a total of 4-6 cycles.
Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China