Actively Recruiting
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
Led by Sun Yat-sen University · Updated on 2025-04-16
88
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
C
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 months and 18 years, any gender
- Physical status score of at least 50 on Karnofsky (for those 16 years or older) or Lansky (for those under 16 years)
- Expected survival time of at least 12 weeks
- Heart function with left ventricular ejection fraction (LVEF) of 50% or higher and no significant arrhythmias or myocardial ischemia
- Diagnosed with pediatric rhabdomyosarcoma
- Disease progressed, relapsed, or refractory after first-line treatment
- Measurable lesions per RECIST 1.1 criteria with no recent local treatments
- Fully recovered from acute toxic effects of prior anticancer therapies according to specified timeframes
- Laboratory tests meeting specified thresholds for blood counts, liver and kidney function
- Able to comply with outpatient treatment, laboratory monitoring, and clinical visits
- Parent or guardian able to understand and sign informed consent, with participant capable of assent if applicable
You will not qualify if you...
- Prior treatment with irinotecan combined with temozolomide and vincristine, or prior progression after irinotecan or temozolomide treatment, or prior use of doxorubicin hydrochloride liposome injection chemotherapy
- Use of P450 enzyme-inducing anticonvulsants
- Active or significant cardiovascular disease including heart failure, myocardial infarction, arrhythmias, or LVEF below 50%
- Severe chronic skin diseases
- History of allergic asthma or severe allergic disease
- Poorly controlled hypertension or diabetes
- History of other tumors except cured cervical cancer or basal cell carcinoma
- Positive for hepatitis B surface antigen
- Infection with HIV or syphilis
- Previous organ transplant
- Uncontrolled systemic bacterial, viral, or fungal infection
- Contraindications to high-dose hormone use such as uncontrolled hyperglycemia, gastric ulcers, or mental illness
- Prior use of doxorubicin or epirubicin above specified cumulative doses or prior anthracycline-induced heart disease
- History of severe neurological or psychiatric disorders including epilepsy or autism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
Y
Yzhuo Zhang, PhD
CONTACT
J
Juan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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