RecruitingPhase 2NCT06761417

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

Enrollment

49 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anlotinib, a drug called Capecitabine, and others for people with adolescents, children, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMitoxantrone liposome

Mitoxantrone liposome: 16 mg/m\^2, d1; Each 21-day cycle was used for a total of 4-6 cycles.

DRUGCapecitabine

Capecitabine 1000 mg/m\^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles.

DRUGAnlotinib

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

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NCT06761417


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