This study is a prospective, open label, randomized controlled clinical trial aimed at patients with Ewing's sarcoma who have not received systematic anti-tumor treatment in the past. The aim is to evaluate the efficacy and safety of prophylactic use of Trilaciclib before VDC+IE chemotherapy.
Patients with Ewing's sarcoma who have not received systemic anti-tumor therapy in the past will be screened for qualified subjects who meet the inclusion criteria after signing informed consent. Eligible patients will be randomly divided into an experimental group and a control group in a 1:1 ratio. The control group will receive alternating VDC+IE chemotherapy for 3 weeks, a total of 17 cycles, or until disease progression, intolerable adverse reactions, or withdrawal of informed consent occur. The experimental group received VDC+IE alternating chemotherapy combined with Trilaciclib, with 3 weeks as one course of treatment, for a total of 17 cycles or until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other situations specified in the protocol where treatment should be discontinued. Both the control group and the experimental group can receive supportive nursing treatment according to clinical needs.
Age ≥ 14 years old and ≤ 40 years old;
Histologically confirmed Ewing's sarcoma;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1;
Have not received any anti-tumor treatment other than surgery in the past;
Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;
Subjects who cannot accept or tolerate this chemotherapy regimen for various reasons;
Biopsy confirmed a patient with bone marrow infiltration;
The patient has undergone significant surgical procedures unrelated to Ewing's sarcoma within the 4 weeks prior to enrollment, or has not fully recovered from such surgical procedures;
Parallel
Chemotherapy
DrugVincristine (V), intravenous injection, 1.5 mg/m2 (maximum not exceeding 2mg), D1, odd cycle administration Doxorubicin (D), intravenous infusion, 75mg/m2, D1, odd cycle administration When the cumulative dose of doxorubicin is ≥ 375mg/m2, replace it with actinomycin D 1.25mg/m2 Cyclophosphamide (C), intravenous infusion, 1200mg/m2, D1, odd cycle administration Ifosfamide (I), intravenous infusion, 1800mg/m2, D1-5, even cycle administration Etoposide (E), intravenous infusion, 100mg/m2, D1-5, even cycle administration
Trilaciclib Injection [Cosela]
DrugTrilaciclib, intravenous infusion, 240 mg/m2, administered following chemotherapy (2 hours after completion of vincristine administration and within 4 hours before administration of other chemotherapy drugs)
Duration of 4th degree neutropenia in the first treatment cycle
The time for neutrophil count to recover to ≥ 0.5 × 10^9/L in the first treatment cycle
The incidence of febrile neutropenia during the first to fourth treatment cycles
The incidence of grade 3 or higher neutropenia in the first to fourth treatment cycles
The incidence of grade 3 or higher thrombocytopenia in the first to fourth treatment cycles
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