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OncoMatch/Clinical Trials/NCT06699472

A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Is NCT06699472 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chemotherapy and Trilaciclib for ewing sarcoma.

Phase 2RecruitingFudan UniversityNCT06699472Data as of May 2026

Treatment: Chemotherapy · TrilaciclibThis 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-tumor treatment

Exception: surgery and radiation therapy

Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 100 g/L (no transfusion or erythropoietin dependence within 14 days)

Kidney function

serum creatinine ≤ 1.25x ULN, or creatinine clearance rate ≥ 60 mL/min; urine protein <2+ (if ≥2+, 24-hour urine protein <1g)

Liver function

serum total bilirubin ≤ 1.25x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN for patients with liver metastases); serum albumin ≥ 30 g/L; ALP ≤ 5x ULN

Cardiac function

No history of heart failure or systolic dysfunction (LVEF<50%); no high risk uncontrolled arrhythmias; no significant ventricular arrhythmias; no Mobitz II second or third degree AV block; no angina requiring anti-angina drugs; no clinically significant heart valve disease; no transmural myocardial infarction on ECG; no poorly controlled hypertension (SBP>180mmHg and/or DBP>100mmHg)

Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment ... see full text for details

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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