Phase
Condition
Infantile Fibrosarcoma
Ewing's Family Tumors
Bone Diseases
Treatment
Chemotherapy
Trilaciclib Injection [Cosela]
Clinical Study ID
Ages 14-40 All Genders
Study Summary
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
Connect with a study center
Fudan University Shanghai Cencer Center,
Shanghai, Shanghai 200032
ChinaActive - 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.