RecruitingPhase 2

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

China49 participantsStarted 2025-01-24

Plain-language 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.

Who can participate

Age range6 Years – 24 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient fully understands this study, voluntarily participates and signs the informed consent form (ICF).
✓. Age: children (6 - 12 years old), adolescents (13 - 18 years old) and young adults (19 - 24 years old) (CAYA). The expected survival time is \> 3 months.
✓. Diagnosed with relapsed and refractory solid tumors by histopathology, and it is one of the following subtypes: (1) bone and soft tissue tumors; (2) neuroblastoma; (3) other types of solid tumors that the investigator deems eligible for enrollment.
✓. There must be measurable tumor lesions by CT, enhanced CT, PET/CT or MRI.
✓. Karnofsky score \> 50; ECOG score ≤ 2.
✓. Bone marrow function: neutrophil count \> 1.5 × 10⁹/L, platelet count \> 75 × 10⁹/L, hemoglobin ≥ 80 g/L.
✓. Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT \< 2.5 times the upper limit of normal value (for patients with liver invasion \< 5 times the upper limit of normal value); total bilirubin \< 1.5 times the upper limit of normal value (for patients with liver invasion \< 3 times the upper limit of normal value).
✓. No history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, no history of clinically severe pericardial disease, or no electrocardiogram evidence of acute ischemic or active conduction system abnormality within 6 months before recruitment.

What they're measuring

Rate of Objective response(ORR)

Timeframe: Up to 6 cycles of chemotherapy (each cycle is 21 days)

Trial details

NCT IDNCT06761417

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Sidan Li

+86-0316-5917421 lisidan2006@126.com

View on ClinicalTrials.gov More Solid Tumors trials

Plain-language summary

Who can participate

Age range6 Years – 24 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient fully understands this study, voluntarily participates and signs the informed consent form (ICF).
✓. Age: children (6 - 12 years old), adolescents (13 - 18 years old) and young adults (19 - 24 years old) (CAYA). The expected survival time is \> 3 months.
✓. Diagnosed with relapsed and refractory solid tumors by histopathology, and it is one of the following subtypes: (1) bone and soft tissue tumors; (2) neuroblastoma; (3) other types of solid tumors that the investigator deems eligible for enrollment.
✓. There must be measurable tumor lesions by CT, enhanced CT, PET/CT or MRI.
✓. Karnofsky score \> 50; ECOG score ≤ 2.
✓. Bone marrow function: neutrophil count \> 1.5 × 10⁹/L, platelet count \> 75 × 10⁹/L, hemoglobin ≥ 80 g/L.
✓. Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT \< 2.5 times the upper limit of normal value (for patients with liver invasion \< 5 times the upper limit of normal value); total bilirubin \< 1.5 times the upper limit of normal value (for patients with liver invasion \< 3 times the upper limit of normal value).
✓. No history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, no history of clinically severe pericardial disease, or no electrocardiogram evidence of acute ischemic or active conduction system abnormality within 6 months before recruitment.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria