Идёт набор NCT06714383

Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Фаза II С лечением Osteosarcoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Trilaciclib, Pirarubicin, Lobaplatin.
Кому может быть актуально: Состояния в реестре: Osteosarcoma. Базовые параметры: 14 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат Trilaciclib
Trilaciclib: 240mg/m2, IV, within 4 hours before each chemotherapy agent infused.
Препарат Pirarubicin
Pirarubicin: 60 mg/m2，IV，d1-2
Препарат Lobaplatin
LobaplLatin: 40 mg/m2,，IV，d1

Первичные конечные точки

Incidence of grade 3/4 neutropenia [Срок оценки: up to 30 days]

Вторичные конечные точки (12)

Duration of grade 3/4 neutropenia [Срок оценки: up to 30 days]
Incidence of grade 3/4 thrombocytopenia [Срок оценки: up to 30 days]
Incidence of grade 3 or 4 anemia [Срок оценки: up to 30 days]
Incidence of febrile neutropenia [Срок оценки: up to 30 days]
Usage of granulocyte colony-stimulating factor (G-CSF) [Срок оценки: up to 30 days]
Usage of Thrombopoietin (TPO) [Срок оценки: up to 30 days]
Usage of Erythropoietin (ESA) [Срок оценки: up to 30 days]
Incidence of platelet transfusion [Срок оценки: up to 30 days]
Incidence of red blood cell transfusion [Срок оценки: up to 30 days]
Usage of ferralia [Срок оценки: up to 30 days]
chemotherapy dose reduction of any cause [Срок оценки: up to 30 days]
AE adverse event adverse event adverse event [Срок оценки: up to 30 days]

Критерии участия

Критерии включения

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.