Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* Aged 3 to 18 years (inclusive) at the time of informed consent signing.
* Pathologically confirmed relapsed or refractory malignant solid tumors (including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, osteosarcoma).
* At least one measurable lesion (as defined by RECIST v1.1) confirmed by CT/MRI within 28 days prior to enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Adequate organ function (absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90g/L; serum creatinine ≤1.5×upper limit of normal \[ULN\] for age; total bilirubin ≤1.5×ULN; alanine aminotransferase/aspartate aminotransferase ≤2.5×ULN, or ≤5×ULN if liver metastasis exists).
* Written informed consent provided by the subject (if ≥18 years old) or legal guardian (if \<18 years old).

Exclusion Criteria:

* Known hypersensitivity to any component of the study drugs (liposomal irinotecan, vincristine, temozolomide, anlotinib).
* Active systemic infection requiring systemic antibiotic treatment within 7 days prior to enrollment.
* History of severe cardiovascular disease (e.g., congestive heart failure, uncontrolled arrhythmia).
* Concurrent participation in another interventional clinical trial.
* Pregnancy, lactation, or unwillingness to use effective contraception (for sexually active subjects).
* Other medical conditions that, in the investigator's judgment, may affect study participation or outcome assessment.