Status:
NOT_YET_RECRUITING
Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma
Lead Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Conditions:
Osteosarcoma
Eligibility:
All Genders
12-50 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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.Patients diagnosed by ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06217003
Start Date
February 1 2024
End Date
August 1 2025
Last Update
January 22 2024
Active Locations (1)
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1
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100