BridgeMD
Compares treatment options for Rhabdomyosarcoma, Child
Official title Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical Study
ClinicalTrials.gov ID: NCT05457829
What this study is testing
What is Doxorubicin Hydrochloride Liposome+Irinotecan?
Doxorubicin Hydrochloride Liposome+Irinotecan is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for rhabdomyosarcoma, child.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 relapsed and refractory pediatric rhabdomyosarcoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 6 months ≤age≤18 years, no gender limitation;
- The Karnofsky (≥16 years old) or Lansky (\< 16 years old) physical status score is at least 50;
- The expected survival time is not less than 12 weeks;
- Heart function: A) Cardiac COLOR ultrasound detection LVEF≥ 50%; B) EKG suggests no myocardial ischemia;C) No history of arrhythmia requiring drug...
- Patients who meet the clinical diagnostic criteria and are diagnosed with pediatric rhabdomyosarcoma;
You likely can't join if
- Patients who had previously received irinotecan combined with temozolomide and vincristine, or who had progressed after treatment with irinotecan or...
- Patients with central nervous system metastases;
- P450 enzyme-induced anticonvulsants (anticonvulsants affect irinotecan clearance);
- Previous or concurrent clinical significance of active cardiovascular diseases, including congenital heart disease or pericardial disease, history of...
- Severe chronic skin diseases in the past;
- Previous allergic asthma or severe allergic disease;
See the full eligibility criteria
- 6 months ≤age≤18 years, no gender limitation;
- The Karnofsky (≥16 years old) or Lansky (\< 16 years old) physical status score is at least 50;
- The expected survival time is not less than 12 weeks;
- Heart function: A) Cardiac COLOR ultrasound detection LVEF≥ 50%; B) EKG suggests no myocardial ischemia;C) No history of arrhythmia requiring drug intervention before enrollment;
- Patients who meet the clinical diagnostic criteria and are diagnosed with pediatric rhabdomyosarcoma;
- Patients who have progressed, relapsed or refractory after treatment (failed to achieve complete or partial response after recent treatment);
- Measurable lesions (according to RECIST 1.1 standards, CT scan length of tumor lesions ≥10mm, CT scan short diameter of lymph node lesions ≥15mm, measurable lesions have not received radiotherapy, freezing and other...
- The patient must fully recover from the acute toxic effects of all previous anticancer chemotherapy: A) Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (42 days if...
- Laboratory tests during screening should meet the following conditions: A) Absolute value of neutrophils (ANC) ≥1.5×109/L (if bone marrow invasion, ANC≥1.0×109/L); B) Platelet count (PLT) ≥75×109/L (PLT≥50×109/L for...
- Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
- The parent/guardian of the child or adolescent subject is capable of understanding, agreeing to, and signing the study Informed consent (ICF) and the applicable child consent form prior to initiating any program-related...
- Patients who had previously received irinotecan combined with temozolomide and vincristine, or who had progressed after treatment with irinotecan or temozolomide, or who had previously received doxorubicin hydrochloride...
- Patients with central nervous system metastases;
- P450 enzyme-induced anticonvulsants (anticonvulsants affect irinotecan clearance);
- Previous or concurrent clinical significance of active cardiovascular diseases, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart...
- Severe chronic skin diseases in the past;
- Previous allergic asthma or severe allergic disease;
- Poorly controlled hypertension and diabetes;
- Have a history of other tumors, except cured cervical cancer or basal cell carcinoma of the skin;
- Hepatitis B surface antigen positive patients;
- HIV or syphilis infected patients;
- Patients who have previously received organ transplants;
- Uncontrolled and active systemic bacterial, viral or fungal infection;
- Contraindications to the use of large doses of hormones, such as uncontrolled hyperglycemia, gastric ulcers or mental diseases;
- Patients who had used doxorubicin at a cumulative dose of ≥450 mg/m2, or epirubicin at a cumulative dose of ≥ 550 mg/m2, or who had used anthracyclines in the past to induce heart disease;
- Have a history of severe neurological or psychiatric disorders, including epilepsy or autism.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.