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.
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.
Patients with known hypersensitivity to any component of the study drugs.
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).
Pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures.
Other situations judged by the investigator as not suitable for participating in this study.
Single group
Mitoxantrone liposome
DrugMitoxantrone liposome: 16 mg/m\^2, d1; Each 21-day cycle was used for a total of 4-6 cycles.
Capecitabine
DrugCapecitabine 1000 mg/m\^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles.
Anlotinib
DrugAnlotinib: according to patient weight: 8mg/ day in patients \<35kg; 10mg/ day for patients with 35kg≤ patient weight ≤50kg; 12mg/ day for patients \> 50kg; d1-14; Each 21-day cycle was used for a total of 4-6 cycles.
Rate of Objective response(ORR)
Rate of Objective response (ORR) after 4 or 6 cycles of Liposomal Mitoxantrone Combination Regimen, including complete response (CR) and partial response (PR)
Rate of Disease control (DCR)
Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy
Progression-free survival (PFS)
Means from the date of enrollment to the date of first disease progression or death from any cause, whichever comes first. If the subject has no disease progression during the trial period, PFS is defined as the last date until the subject's last confirmed progression-free survival.
Overall survival (OS)
Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.
Proportion of patients eligible for local treatment after treatment
Proportion of patients who meet the conditions for local treatment after treatment. mathematically, it can be expressed as: Proportion = (Number of patients eligible for local treatment / Total number of patients in the study) × 100%.
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