RecruitingPhase 2NCT05457829

Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of First Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical Study


Sponsor

Sun Yat-sen University

Enrollment

88 participants

Start Date

Dec 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter, randomized, controlled, open-label, prospective clinical trial was designed to evaluate the efficacy and safety of doxorubicin hydrochloride liposome injection in combination with irinotican (AI regimen) versus VIT regimen in the treatment of first relapsed and refractory pediatric rhabdomyosarcoma.


Eligibility

Min Age: 6 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy combinations for children and teens whose rhabdomyosarcoma (a type of muscle cancer) has come back or did not respond to initial treatment. One combination includes liposomal doxorubicin and irinotecan; the other uses vincristine, irinotecan, and temozolomide. **You may be eligible if...** - You are between 6 months and 18 years old - You have rhabdomyosarcoma that has returned or not responded to first treatment - Your heart function is adequate (confirmed by echo and ECG) - You are well enough to carry out some daily activities (performance score of at least 50) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have serious heart, liver, kidney, or bone marrow problems - You have active, uncontrolled infection - You are pregnant or breastfeeding - Your cancer is in the eye socket (orbital) with no other spread Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDoxorubicin Hydrochloride Liposome+Irinotecan

Q3W, 2 cycles.

DRUGTemozolomide+Irinotecan+Vincristine

Q3W, 2 cycles.


Locations(1)

Sun Yat-Sen University Cancer Center

Guangzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05457829