Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

NCT06714383 | Recruiting Phase 2

• 1 other identifier: SMA-OS-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3/4 neutropenia

  Incidence of grade 3/4 neutropenia up to 30 days

  up to 30 days

Secondary Outcomes (14)

• Duration of grade 3/4 neutropenia

  up to 30 days

• Incidence of grade 3/4 thrombocytopenia

  up to 30 days

• Incidence of grade 3 or 4 anemia

  up to 30 days

• Incidence of febrile neutropenia

  up to 30 days

• Usage of granulocyte colony-stimulating factor (G-CSF)

  up to 30 days

Study Arms (2)

Trilaciclib Arm

EXPERIMENTAL

Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin

Drug: Trilaciclib; Drug: Pirarubicin; Drug: Lobaplatin

Control Arm

SHAM COMPARATOR

Neoadjuvant therapy of Pirarubicin and Lobaplatin

Drug: Pirarubicin; Drug: Lobaplatin

Interventions

Trilaciclib DRUG

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

Also known as: Cosela

Trilaciclib Arm

Pirarubicin DRUG

Pirarubicin: 60 mg/m2，IV，d1-2

Control Arm; Trilaciclib Arm

Lobaplatin DRUG

LobaplLatin: 40 mg/m2,，IV，d1

Control Arm; Trilaciclib Arm

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent signed;
• Classic osteosarcoma confirmed by histopathology (high grade);
• Newly diagnosed stage Ⅱ-Ⅲ based on Enneking staging criteria;
• Planned to receive neoadjuvant chemotherapy;
• Measurable disease on CT by RECIST 1.1.
• No antitumor system therapy received;
• ECOG 0-1
• Adequate organ function.
• 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.

You may not qualify if:

• History of malignancies of other type;
• Allergic to study agent;
• History of psychotropic substance abuse, alcohol or drug use;
• The researchers considered inappropriate to join the study of any cause.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Interventions

trilaciclib; pirarubicin; lobaplatin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: December 3, 2024
• Study Start: November 13, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CN (1)