A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
This study is an open, multi-cohort phase II clinical trial, the overall design is divided
into two parts: dose confirmation stage and expansion stage. Dose confirmation stage is to
evaluate the safety and tolerability of three dosing regimenes of docetaxel polymer micelle
for injection in patients with advanced esophageal cancer, and to determine the best dosing
regimenes for entering the expansion stage. The expansion stage iwas used to evaluate the
efficacy and further safety of the best dosing regimen identified in the dose confirmation
stage in patients with advanced solid tumors. All subjects in the dose confirmation stage and
expansion stage will continue treatment according to the injection docetaxel micelle regimen
they received at enrollment until the disease progresses or the investigator determines that
continuing treatment with the study drug will not benefit, or any intolerable toxicity
occurs, or they voluntarily withdraw, or for other reasons, whichever occurs first.