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

Last updated: November 19, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

2

Condition

Infantile Fibrosarcoma

Ewing's Family Tumors

Bone Diseases

Treatment

Chemotherapy

Trilaciclib Injection [Cosela]

Clinical Study ID

NCT06699472
2409305-18
  • Ages 14-40
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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;

  • Expected survival of more than 3 months;

  • Possess sufficient organ and bone marrow function, with laboratory test valuesmeeting the following requirements within 7 days prior to enrollment (no bloodcomponents, cell growth factors, albumin, or other corrective treatment drugs areallowed within 14 days prior to obtaining laboratory tests), as follows Bloodroutine: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 100 g/L (no transfusion or erythropoietin dependencewithin 14 days) Liver function: serum total bilirubin ≤ 1.25 times the upper limitof normal (ULN); ALT and AST ≤ 2.5 x ULN (≤ 5x ULN for patients with livermetastases); Serum albumin ≥ 30 g/L; Alkaline phosphatase (ALP) ≤ 5 × ULN.

Renal function: Serum creatinine (Cr) ≤ 1.25 × ULN, or creatinine clearance rate ≥ 60 mL/min (using the standard Cockcroft Gault formula): Urine routine results show urinary protein<2+; For patients whose baseline urine routine test shows urinary protein ≥ 2+, 24-hour urine collection should be performed with a 24-hour urine protein quantification of<1g.

Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of use of the anticoagulant drug.

  • For female subjects of childbearing age, a urine or serum pregnancy test should beconducted 3 days before receiving the first study drug and the result should benegative;

  • The subjects and their sexual partners are required to use a medically approvedcontraceptive measure (such as intrauterine device, contraceptive pill, or condom)during the study treatment period and within 6 months after the end of the studytreatment period.

Exclusion

Exclusion Criteria:

  • Previously received anti-tumor treatment other than surgery and radiation therapyfor any malignant tumor;

  • Subjects who cannot accept or tolerate this chemotherapy regimen for variousreasons;

  • Biopsy confirmed a patient with bone marrow infiltration;

  • The patient has undergone significant surgical procedures unrelated to Ewing'ssarcoma within the 4 weeks prior to enrollment, or has not fully recovered from suchsurgical procedures;

  • Serious heart disease or discomfort, including but not limited to the followingdiseases:

Diagnosed history of heart failure or systolic dysfunction (LVEF<50%); High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block); Angina requiring treatment with anti angina drugs; Clinically significant heart valve disease; ECG shows transmural myocardial infarction; Poor control of hypertension (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg)

  • Individuals with a known history of allergies to the components of this medicationregimen;

  • Breastfeeding female patients, female patients with fertility and positive baselinepregnancy test results, or reproductive age patients who are unwilling to takeeffective contraceptive measures during the entire trial period and within 7 monthsafter the last study medication;

  • The researchers believe that the patient is not suitable to participate in any othercircumstances of this study.

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Chemotherapy
Phase: 2
Study Start date:
October 31, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Fudan University Shanghai Cencer Center,

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.