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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | November 13, 2024 |
| Main results expected | July 2025 |
| Study ends | November 2025 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT06714383 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.
-
Fight Osteosarcoma with a European, evolving research platform from diagnosis to relapse
A European platform trial in pediatric and young adult high-grade osteosarcoma will test Cabometyx as one treatment option while collecting tumor and blood samples to guide future strategies.
-
Immunotherapy plus standard treatment for high-risk osteosarcoma in kids and young adults
This study tests mifamurtide added to standard chemotherapy versus standard treatment with sorafenib to see if the combination helps patients with high-risk osteosarcoma.
-
68Ga-B7-H3 Nanobody PET Imaging in Osteosarcoma
This study tests a new gallium-68 labeled B7-H3 nanobody to see if it can image osteosarcoma tumors more clearly.
-
Domatinostat with Sirolimus for relapsed or refractory sarcoma and osteosarcoma
This study tests whether the cancer drugs domatinostat and sirolimus together can help adolescents and adults whose sarcoma or osteosarcoma has come back or stopped responding to standard therapy.
-
Neoantigen Vaccine SarVac With Tumor-Specific Lymphocytes Plus PD-1 Blocker for Advanced Sarcoma
This trial tests a personalized cancer vaccine called SarVac, given with a PD-1 blocker, and possibly tumor-specific lymphocytes, to see if it is safe and can help people with advanced soft tissue or bone sarcoma.
-
Methionine-Reduced Diet in Solid Tumors (early-phase)
A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.