Liposomal mitoxantrone combined with capecitabine and anlotinib for relapsed and refractory solid tumors in children, adolescents, and young adults

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

This treatment tests whether a liposomal mitoxantrone combination (with capecitabine and anlotinib) can shrink relapsed or refractory solid tumors in children, adolescents, and young adults.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 6 Years to 24 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: anlotinib
• Locations: 1 site (Beijing)
• Trial ID: NCT06761417 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multicenter Phase 2 study enrolling about 49 patients aged 6–24 with histologically confirmed relapsed or refractory measurable solid tumors. Participants receive liposomal mitoxantrone combined with oral capecitabine (1000 mg/m² twice daily on days 1–14) and weight‑adjusted anlotinib in 21‑day cycles for 4–6 cycles, with safety and dose adjustments per protocol. The primary goal is to compare objective response rate (ORR) to historical controls, and secondary monitoring includes adverse events, laboratory parameters, and imaging-based tumor assessments by CT, MRI or PET/CT. Patients undergo regular clinical and laboratory evaluations during treatment and a defined follow-up period to characterize toxicity and durability of response.

Who should consider this trial

Good fit: Ideal candidates are patients aged 6–24 with histologically confirmed relapsed or refractory measurable solid tumors, expected survival >3 months, adequate marrow/liver/kidney function, and ECOG ≤2 or Karnofsky >50.

Not a fit: Patients who are pregnant or lactating, have hypersensitivity to the study drugs, uncontrolled other malignancies or significant organ dysfunction are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the regimen could raise tumor response rates and provide a new treatment option for children, adolescents, and young adults with relapsed or refractory solid tumors.

How similar studies have performed: Related combinations using capecitabine or tyrosine kinase inhibitors have shown activity in some adult solid tumors, but this specific liposomal mitoxantrone plus capecitabine and anlotinib combination in pediatric relapsed/refractory solid tumors is novel and not well tested.

Eligibility criteria

Main inclusion Criteria:

1. The patient fully understands this study, voluntarily participates and signs the informed consent form (ICF).
2. 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.
3. 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.
4. There must be measurable tumor lesions by CT, enhanced CT, PET/CT or MRI.
5. Karnofsky score \> 50; ECOG score ≤ 2.
6. Bone marrow function: neutrophil count \> 1.5 × 10⁹/L, platelet count \> 75 × 10⁹/L, hemoglobin ≥ 80 g/L.
7. 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).
8. 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.

Main exclusion Criteria:

1. Patients with known hypersensitivity to any component of the study drugs.
2. Patients with other malignant tumors that are not under control (except for basal cell carcinoma of the skin, in-situ breast/cervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years).
3. Pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures.
4. Other situations judged by the investigator as not suitable for participating in this study.

Where this trial is running

Beijing

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Sidan Li

Conditions: Solid Tumors, Children, Adolescents, Mitoxantrone liposomes, Solid tumor, Children and adolescents