Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.

Inclusion Criteria:

• 2 years ≤age≤21 years, no gender limitation.

• The Karnofsky (≥16 years old) or Lansky (< 16 years old) physical status score is atleast 70.

• The expected survival time is not less than 12 weeks.

• Heart function: a) Cardiac COLOR ultrasound detection LVEF≥ 50%; b) ECG suggests nomyocardial ischemia; c) No history of arrhythmia requiring drug intervention beforeenrollment.

• Pathological results for patients of soft tissue sarcoma.

• Patients with rhabdomyosarcoma are limited to first -, second -, and third-linetreatment, and patients with other pathological subtypes are limited to progression,recurrence, or refractory after first-line treatment, with refractory defined asfailure to achieve complete or partial response to the most recent treatment.

• Measurable lesions (according to RECIST 1.1 standards, measurable lesions have notreceived radiotherapy, freezing and other local treatments).

• The patient must fully recover from the acute toxic effects of all previousanticancer chemotherapy.

• Good blood and organ function.

• During study participation, patients are able to adhere to outpatient treatment,laboratory monitoring, and necessary clinical visits.

• 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 childconsent form prior to initiating any program-related procedures; Subject is capableof expressing consent with parental/guardian consent (if applicable).

Exclusion Criteria:

• Once received mitoxantrone or mitoxantrone liposomes.

• Patients who had received previous VIT (irinotecan + temozolomide + vincristine)chemotherapy.

• Previous treatment with adriamycin or other anthracyclines with a total cumulativedose of adriamycin > 360 mg/m^2; Or patients with cardiac disease caused by previousanthracyclines.

• Receiving or not being able to discontinue P450 enzyme-induced anticonvulsant drugs (e.g., phenytoin, carbamazepine, etc.) within 4 weeks or 5 half-life periods priorto enrollment.

• Previous or concurrent clinical significance of active cardiovascular diseases.

• Severe chronic skin diseases in the past.

• Previous allergic asthma or severe allergic disease.

• Uncontrolled hypertension and diabetes.

• Have a history of other tumors, except cured cervical cancer or basal cell carcinomaof the skin.

• Active hepatitis B or hepatitis C infection.

• HIV or syphilis infected patients.

• Patients who have previously received organ transplants.

• Uncontrolled active systemic bacterial, viral, or fungal infection.

• Contraindications to high-dose hormone use, such as uncontrolled hyperglycemia,gastric ulcers, or psychiatric disorders.

• Severe neurological or psychiatric history, including epilepsy or autism.

• Pregnant, lactating women and patients of childbearing age who are unwilling to usecontraception.

• Other circumstances deemed inappropriate by the investigator to participate in thestudy.