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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
22
Vincristine (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, 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)
Fudan University Shanghai Cencer Center,
Shanghai, Shanghai Municipality, China
RECRUITINGDuration of 4th degree neutropenia in the first treatment cycle
Time frame: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The time for neutrophil count to recover to ≥ 0.5 × 10^9/L in the first treatment cycle
Time frame: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The incidence of febrile neutropenia during the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 or higher neutropenia in the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 or higher thrombocytopenia in the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of grade 3 anemia or above during the first to fourth treatment cycles
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The number of times and frequency of reduction of all cause chemotherapy drugs
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The number of cycles of the first reduction of chemotherapy drugs
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
The incidence of infectious serious adverse events
Time frame: From enrollment to the end of Cycle 4 (each cycle is 21 days)
EFS
Event Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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