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Myeloprotection With Trilaciclib in Pan-cancer Population
Sponsor: Sun Yat-sen University
Summary
The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are: * effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy * does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.
Official title: Efficacy and Safety of Trilaciclib in Myeloprotection During Chemotherapy for Advanced/Recurrent Malignant Solid Tumors - A Phase II Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2024-03-01
Completion Date
2027-12-31
Last Updated
2024-03-07
Healthy Volunteers
No
Conditions
Interventions
Trilaciclib Injection
Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection \[Cosela\] 240 mg/m\^2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
Paclitaxel
Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.
Carboplatin
area under curve(AUC) 5\~6, intravenous drip over ≥ 1 hours, d1, Q3W, at least 6 cycles.
Locations (1)
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China