Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trilaciclib, Pirarubicin, Lobaplatin.
- Who it may be relevant to
- Registry conditions: Osteosarcoma. Basic parameters: 14 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
Overview
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.
Interventions
- Drug Trilaciclib
Trilaciclib: 240mg/m2, IV, within 4 hours before each chemotherapy agent infused. - Drug Pirarubicin
Pirarubicin: 60 mg/m2，IV，d1-2 - Drug Lobaplatin
LobaplLatin: 40 mg/m2,，IV，d1
Primary outcome measures
- Incidence of grade 3/4 neutropenia [Time frame: up to 30 days]
Secondary outcome measures (12)
- Duration of grade 3/4 neutropenia [Time frame: up to 30 days]
- Incidence of grade 3/4 thrombocytopenia [Time frame: up to 30 days]
- Incidence of grade 3 or 4 anemia [Time frame: up to 30 days]
- Incidence of febrile neutropenia [Time frame: up to 30 days]
- Usage of granulocyte colony-stimulating factor (G-CSF) [Time frame: up to 30 days]
- Usage of Thrombopoietin (TPO) [Time frame: up to 30 days]
- Usage of Erythropoietin (ESA) [Time frame: up to 30 days]
- Incidence of platelet transfusion [Time frame: up to 30 days]
- Incidence of red blood cell transfusion [Time frame: up to 30 days]
- Usage of ferralia [Time frame: up to 30 days]
- chemotherapy dose reduction of any cause [Time frame: up to 30 days]
- AE adverse event adverse event adverse event [Time frame: up to 30 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06714383 · SMA-OS-001