A Phase II Clinical Study of Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

HSKY028

This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of trilaciclib before perioperative chemotherapy in patients with osteosarcoma.

2024-02-01

2025-02-01

2025-08-01

Not yet recruiting

Early phase I

20

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-01-22