Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

NCT06217003 | Unknown Phase 2

• 1 other identifier: HSKY028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of trilaciclib before perioperative chemotherapy in patients with osteosarcoma.

Conditions

Osteosarcoma

Keywords

Osteosarcoma; Perioperative period; Trilaciclib; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• The incidence of grade ≥ 3 neutropenia during chemotherapy treatment

  Is the number of neutrophils in the blood routine test lower than the ninth power of 1.0 \* 10/L

  1-2 weeks after chemotherapy

Secondary Outcomes (3)

• The incidence of grade 4 neutropenia during chemotherapy treatment

  1-2 weeks after chemotherapy

• The occurrence of grade 3 or grade 4 thrombocytopenia during chemotherapy treatment

  1-3 weeks after chemotherapy

• The incidence of grade 3 or 4 anemia during chemotherapy treatment

  1-3 weeks after chemotherapy

Study Arms (1)

trilaciclib

EXPERIMENTAL

Screening of eligible subjects for inclusion and application of trilaciclib before undergoing perioperative chemotherapy

Drug: Trilaciclib

Interventions

Trilaciclib DRUG

Preoperative application of trilaciclib during perioperative chemotherapy

trilaciclib

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old ≤ Age ≤ 50 years old, regardless of gender;
• Patients diagnosed by pathology and evaluated by surgeons as having unmetastased resectable osteosarcoma
• The patient's laboratory test meets the standards
• Cardiac echocardiography must meet the following criteria: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
• ECOG PS score 0-1 points;
• Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose;
• Understand and sign the informed consent form.

You may not qualify if:

• Diagnosed as other malignant diseases outside of osteosarcoma within 5 years prior to initial administration (excluding curative basal cell carcinoma, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ);
• Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
• Stroke or cardiovascular events within 6 months prior to enrollment;
• When screening, QTcF interval\>480msec, for patients with implanted ventricular pacemakers, QTcF\>500msec
• Previously received hematopoietic stem cell or bone marrow transplantation;
• Allergy to the investigational drug or its components;
• The researchers believe that it is not suitable to participate in this study.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

trilaciclib

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: August 2024 to June 2025

Locations

CN (1)