The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are:
* Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim? * How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety.
Participants will:
* Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle. * Undergo blood tests, physical exams, and temperature monitoring during follow-up visits. * Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker). * Complete two chemotherapy cycles with close safety and efficacy monitoring.
Previous febrile neutropenia(FN) or dose-limiting neutropenia in the prior chemotherapy cycle without prophylactic granulocyte colony-stimulating factor (G-CSF);
Previous FN or dose-limiting neutropenia in the prior chemotherapy cycle despite prophylactic G-CSF.
Age ≥6 to ≤24 years.
Eastern Cooperative Oncology Group Performance Status ≤1.
Bone marrow involvement at screening.
Uncontrolled localized or systemic infection.
Known hypersensitivity to Telpegfilgrastim, recombinant human granulocyte-colony stimulating factor(rhG-CSF), or other pegylated recombinant human granulocyte colony stimulating factor(PEG-rhG-CSF) agents.
Concurrent participation in any other investigational drug or device trial.
Parallel
Telpegfilgrastim Injection
Drugsubcutaneous injections of Telpegfilgrastim (33 μg/kg, single dose) 24 hours after each chemotherapy cycle
filgrastim
Drugsubcutaneous injections of Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle
Incidence of febrile neutropenia in Cycle 1
Incidence of febrile neutropenia in Cycle 1 (i.e., the first chemotherapy cycle post-enrollment)
Incidence of grade 3 neutropenia during Cycles 1-2
Incidence of grade 3 neutropenia (absolute neutrophil count\<1.0×10\^9/L) during Cycles 1-2
Time to recovery of grade 3 neutropenia during Cycles 1-2
Time to recovery of grade 3 neutropenia (absolute neutrophil count\<1.0×10\^9/L) during Cycles 1-2
Time to recovery of grade 4 neutropenia during Cycles 1-2
Time to recovery of grade 4 neutropenia (absolute neutrophil count \<0.5×10\^9/L) during Cycles 1-2
Incidence of grade 4 neutropenia during Cycles 1-2
Incidence of grade 4 neutropenia (absolute neutrophil count \<0.5×10\^9/L) during Cycles 1-2
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