NCT03387943

PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma

A Prospective, Multicenter, Open Label Phase Ⅱ Clinical Trial of Doxorubicin Hydrochloride Liposome Injection Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.

Detailed description

Subjects will receive the treatment regimen as follow: intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. Stop the treatment if the patients have progressed or intolerated to the toxicity. The primary endpoint is disease control rate(DCR), the secondary endpoint is overall survival (OS), progression-free survival (PFS), safety and quality of life assessment(QoL).

Conditions

• Poorly Differentiated Thyroid Carcinoma

Interventions

Type	Name	Description
DRUG	PLD	intravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles.
DRUG	Cisplatin	cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles.

Timeline

• Start date: 2017-03-06
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2018-01-02
• Last updated: 2018-01-03

Locations

1 site across 1 country: China