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RECRUITING
NCT07662746
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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