drugset / Trial / NCT06761417

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

NCT06761417

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-24
Primary completion
2027-04-01
Completion
2028-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2
Subject Catequentinib Small molecule 8 mg
Subject Catequentinib Small molecule 10 mg
Subject Catequentinib Small molecule 12 mg
Subject Mitoxantrone Small molecule 16 mg/m2

Indications