Using Trilaciclib with Chemotherapy for Osteosarcoma Treatment
A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
This study is testing if adding Trilaciclib to chemotherapy can help protect the bone marrow of patients with stage II/III classic osteosarcoma during treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06714383 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Trilaciclib in protecting bone marrow during neoadjuvant chemotherapy for patients with stage II/III classic osteosarcoma. The study combines Trilaciclib with pirarubicin and lobaplatin to assess its ability to reduce chemotherapy-induced myelosuppression, which can lead to severe complications and affect treatment compliance. By blocking CDK4/6 activity, Trilaciclib aims to preserve hematopoietic stem cells and enhance the overall efficacy of chemotherapy. The trial will involve patients who are newly diagnosed and have measurable disease as confirmed by imaging.
Who should consider this trial
Good fit: Ideal candidates include individuals with newly diagnosed stage II or III classic osteosarcoma who are planned to receive neoadjuvant chemotherapy.
Not a fit: Patients with a history of other malignancies or those who have received prior antitumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the safety and effectiveness of chemotherapy for osteosarcoma patients.
How similar studies have performed: While there are no approved treatments specifically for preventing chemotherapy-induced damage in osteosarcoma, the use of CDK4/6 inhibitors has shown promise in other cancer types, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent signed; 2. Classic osteosarcoma confirmed by histopathology (high grade); 3. Newly diagnosed stage Ⅱ-Ⅲ based on Enneking staging criteria; 4. Planned to receive neoadjuvant chemotherapy; 5. Measurable disease on CT by RECIST 1.1. 6. No antitumor system therapy received; 7. ECOG 0-1 8. Adequate organ function. 9. Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication. Exclusion Criteria: 1. History of malignancies of other type; 2. Allergic to study agent; 3. History of psychotropic substance abuse, alcohol or drug use; 4. The researchers considered inappropriate to join the study of any cause.
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.