Clinical trial · Interventional
Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma
A Phase II Clinical Study of Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma
NCT06217003CI-TRIAL-00073151unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trilaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- trilaciclib
- description
- Screening of eligible subjects for inclusion and application of trilaciclib before undergoing perioperative chemotherapy
- interventionNames
- Drug: Trilaciclib
Primary outcomes (1)
- measure
- The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
- timeFrame
- 1-2 weeks after chemotherapy
- description
- Is the number of neutrophils in the blood routine test lower than the ninth power of 1.0 \* 10/L
Secondary outcomes (3)
- measure
- The incidence of grade 4 neutropenia during chemotherapy treatment
- timeFrame
- 1-2 weeks after chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.