Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Phase 2

Recruiting

• Conditions: Osteosarcoma
• Interventions: Drug: Trilaciclib; Drug: Pirarubicin; Drug: Lobaplatin

• Registration Number: NCT06714383
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Classic osteosarcoma is the most common primary bone malignancy. At present, osteosarcoma is usually treated with preoperative chemotherapy, surgical operation and postoperative chemotherapy. Treatment with preoperative chemotherapy is also known as neoadjuvant chemotherapy. Neoadjuvant chemotherapy has brought benefits to patients, but safety concerns are inevitable. Myelosuppression is a major factor affecting the compliance of patients treated by chemotherapy. Patients with chemotherapy-induced myelosuppression(CIM) have higher rates of infection, sepsis, bleeding, and fatigue, resulting in hospitalization, hematopoietic growth factor support, blood transfusions (red blood cells and/or platelets) and even death. In addition, CIM often leads to dose reduction and delayed administration, which limits the therapeutic dose intensity and therefore affects the anti-tumor efficacy of chemotherapy.

Currently, there are no approved treatments in osteosarcoma to prevent chemotherapy-induced cell damage. Although some treatments may help to address CIM when it occurs such as blood transfusions and growth factors, these treatments are pedigree specific, being used after hematopoietic stem progenitor cells damage and could bring additional toxicity.

Trilaciclib is a highly effective, selective and temporarily reversible inhibitor of CDK4/6. The proliferation of bone marrow hematopoietic stem cells depends on CDK4/6 activity. Bone marrow hematopoietic stem cells are blocked in the G1 phase of the cell cycle after exposure to Trilaciclib before chemotherapy is given.

Therefore, this study is conducted 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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-13
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trilaciclib Arm	Trilaciclib	Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin
Trilaciclib Arm	Pirarubicin	Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin
Trilaciclib Arm	Lobaplatin	Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin
Control Arm	Pirarubicin	Neoadjuvant therapy of Pirarubicin and Lobaplatin
Control Arm	Lobaplatin	Neoadjuvant therapy of Pirarubicin and Lobaplatin

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3/4 neutropenia	up to 30 days	Incidence of grade 3/4 neutropenia up to 30 days

Secondary Outcome Measures

Name	Time	Method
Duration of grade 3/4 neutropenia	up to 30 days	Duration of grade 3/4 neutropenia up to 30 days
Incidence of grade 3/4 thrombocytopenia	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 grade 3 or 4 anemia up to 30 days
Incidence of febrile neutropenia	up to 30 days	Incidence of febrile neutropenia up to 30 days
Usage of granulocyte colony-stimulating factor (G-CSF)	up to 30 days	Utilization rate of granulocyte colony-stimulating factor (G-CSF) up to 30 days
Usage of Thrombopoietin (TPO)	up to 30 days	Utilization rate of Thrombopoietin (TPO) up to 30 days
Usage of Erythropoietin (ESA)	up to 30 days	Utilization rate of Erythropoietin (ESA) up to 30 days
Incidence of platelet transfusion	up to 30 days	Incidence of platelet transfusion up to 30 days
Incidence of red blood cell transfusion	up to 30 days	Incidence of red blood cell transfusion up to 30 days
Usage of ferralia	up to 30 days	Utilization rate of ferralia up to 30 days
chemotherapy dose reduction of any cause	up to 30 days	chemotherapy dose reduction rate of any cause up to 30 days
AE adverse event adverse event adverse event	up to 30 days	adverse event
SAE	up to 30 days	serious adverse event serious adverse event serious adverse event Serious Adverse Event
Termination of treatment caused by AE/SAE	up to 30 days	Termination of treatment rate caused by AE/SAE

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China