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NOT YET RECRUITING
NCT06761417
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Mitoxantrone liposome

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

DRUG

Capecitabine

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

DRUG

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