Actively Recruiting
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
Led by Fudan University · Updated on 2024-11-21
22
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 40 years
- Histologically confirmed diagnosis of Ewing's sarcoma
- ECOG Performance Status score of 0 to 1
- No prior anti-tumor treatment other than surgery
- Expected survival longer than 3 months
- Adequate organ and bone marrow function with specific lab values within 7 days before enrollment:
- Absolute neutrophil count ≥ 1.5 × 10^9/L
- Platelet count ≥ 100 × 10^9/L
- Hemoglobin ≥ 100 g/L without recent transfusions or erythropoietin dependence
- Liver function within defined limits: total bilirubin ≤ 1.25 × ULN, ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN with liver metastases), albumin ≥ 30 g/L, alkaline phosphatase ≤ 5 × ULN
- Renal function with serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min
- Urine protein less than 2+ on routine test or 24-hour urine protein quantification less than 1g if higher
- Coagulation parameters INR or PT ≤ 1.5 × ULN; acceptable if on anticoagulants within intended INR range
- Negative pregnancy test within 3 days before first study drug for females of childbearing potential
- Agreement to use medically approved contraception during and for 6 months after treatment
You will not qualify if you...
- Previous anti-tumor treatments other than surgery or radiation for any malignant tumor
- Inability to tolerate the chemotherapy regimen
- Bone marrow infiltration confirmed by biopsy
- Recent major surgery unrelated to Ewing's sarcoma within 4 weeks or incomplete recovery from surgery
- Serious heart conditions including heart failure, systolic dysfunction (LVEF < 50%), uncontrolled arrhythmias, angina requiring treatment, significant valve disease, transmural myocardial infarction on ECG, or poorly controlled hypertension
- Known allergies to study medications
- Breastfeeding females, positive pregnancy test, or unwillingness to use effective contraception during and for 7 months after treatment
- Any other condition deemed unsuitable for participation by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cencer Center,
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xin Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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