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Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

NCT ID: NCT06714383

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Osteosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Trilaciclib Arm

Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin

Group Type EXPERIMENTAL

Trilaciclib

Intervention Type DRUG

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

Pirarubicin

Intervention Type DRUG

Pirarubicin: 60 mg/m2，IV，d1-2

Lobaplatin

Intervention Type DRUG

LobaplLatin: 40 mg/m2,，IV，d1

Control Arm

Neoadjuvant therapy of Pirarubicin and Lobaplatin

Group Type SHAM_COMPARATOR

Pirarubicin

Intervention Type DRUG

Pirarubicin: 60 mg/m2，IV，d1-2

Lobaplatin

Intervention Type DRUG

LobaplLatin: 40 mg/m2,，IV，d1

Interventions

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Trilaciclib

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

Intervention Type DRUG

Pirarubicin

Pirarubicin: 60 mg/m2，IV，d1-2

Intervention Type DRUG

Lobaplatin

LobaplLatin: 40 mg/m2,，IV，d1

Intervention Type DRUG

Other Intervention Names

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Cosela

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tang Xiaodong

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xin Sun

Role: primary

[email protected]
+86 13810548607

Other Identifiers

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SMA-OS-001

Identifier Type: -

Identifier Source: org_study_id