Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 14 to 70

Using Trilaciclib with Chemotherapy for Osteosarcoma Treatment

Official title: A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Run by Peking University People's Hospital · NCT06714383 · Data updated 2026-11-12

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

PhasePhase 2
Study typeInterventional
Ages14 Years to 70 Years
SexAll
Enrollment50 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedNovember 13, 2024
Main results expectedJuly 2025
Study endsNovember 2025
Registry record updatedDecember 3, 2024
Trial IDNCT06714383 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with newly diagnosed stage II or III classic osteosarcoma who are planned to receive neoadjuvant chemotherapy.

Probably not a fit

Patients with a history of other malignancies or those who have received prior antitumor therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Peking University People's Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.