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Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Summary
Paclitaxel polymeric micelles 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)
Official title: Efficacy and Safety of Paclitaxel Polymeric Micelles in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Exploratory Phase II Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2026-07-01
Completion Date
2029-07-01
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
Paclitaxel polymeric micelles
Paclitaxel polymeric micelles for injection 300 mg/m², IV infusion over ≥3 hours, Day 1; carboplatin AUC 5, IV infusion over 1 hour, Day 1. Each cycle consists of 3 weeks (Q3W), for a total of 3 cycles. (Efficacy assessment will be performed after 3 cycles of treatment. In the absence of disease progression, treatment may be continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death, or other protocol-specified criteria for treatment discontinuation, whichever occurs first.)
Locations (1)
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China