Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07444918
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT07444918
Study Brief:
Protocol Section:
NCT07444918