RecruitingPhase 2NCT06714383

Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

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


Sponsor

Peking University People's Hospital

Enrollment

50 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.


Eligibility

Min Age: 14 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called trilaciclib, given alongside standard chemotherapy, as a pre-surgery (neoadjuvant) treatment for osteosarcoma (a type of bone cancer). Trilaciclib is designed to protect bone marrow during chemotherapy, potentially reducing side effects and improving outcomes. **You may be eligible if...** - You have been newly diagnosed with high-grade osteosarcoma (confirmed by biopsy), stage II or III - You are planning to have neoadjuvant (pre-surgery) chemotherapy - You have not had any previous cancer treatments - You are in good general health (ECOG performance status 0–1) - You have adequate organ function - You agree to use effective contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have a history of another type of cancer - You are allergic to the study drug - You have a history of substance abuse or alcohol use disorder - The investigator determines you are not suitable for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib

Trilaciclib: 240mg/m2, IV, within 4 hours before each chemotherapy agent infused.

DRUGPirarubicin

Pirarubicin: 60 mg/m2,IV,d1-2

DRUGLobaplatin

LobaplLatin: 40 mg/m2,,IV,d1


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06714383


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