Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Sponsor
Peking University People's Hospital
Study ID
NCT06714383
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Trilaciclib — DRUG
    Trilaciclib: 240mg/m2, IV, within 4 hours before each chemotherapy agent infused.
  • Pirarubicin — DRUG
    Pirarubicin: 60 mg/m2，IV，d1-2
  • Lobaplatin — DRUG
    LobaplLatin: 40 mg/m2,，IV，d1

Study Details

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.

Key Dates

First listed
Dec 3, 2024
Start date
Nov 13, 2024
Status verified
Nov 2024
Primary completion
Jul 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Trilaciclib Arm
    Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin
  • Sham Comparator: Control Arm
    Neoadjuvant therapy of Pirarubicin and Lobaplatin

Primary Outcome Measure

Incidence of grade 3/4 neutropenia [ Time Frame: up to 30 days ]

Related Studies