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NOT YET RECRUITING
NCT06297811
PHASE2

Myeloprotection With Trilaciclib in Pan-cancer Population

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

Paclitaxel

Drug: Paclitaxel 175 mg/m\^2, intravenous drip over ≥ 3 hours , d1, Q3W, at least 6 cycles.

DRUG

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