Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT06217003
Eligibility Criteria:
Inclusion Criteria:
* 12 years old ≤ Age ≤ 50 years old, regardless of gender;
* Patients diagnosed by pathology and evaluated by surgeons as having unmetastased resectable osteosarcoma
* The patient's laboratory test meets the standards
* Cardiac echocardiography must meet the following criteria: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
* ECOG PS score 0-1 points;
* Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose;
* Understand and sign the informed consent form.
Exclusion Criteria:
* Diagnosed as other malignant diseases outside of osteosarcoma within 5 years prior to initial administration (excluding curative basal cell carcinoma, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ);
* Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
* Stroke or cardiovascular events within 6 months prior to enrollment;
* When screening, QTcF interval\>480msec, for patients with implanted ventricular pacemakers, QTcF\>500msec
* Previously received hematopoietic stem cell or bone marrow transplantation;
* Allergy to the investigational drug or its components;
* The researchers believe that it is not suitable to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
50 Years
Study:
NCT06217003
Study Brief:
Protocol Section:
NCT06217003