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PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT03387943•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Volunteer to participate and sign the informed consent form;
•2. Age :18-70 years old;
•3. Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
•4. Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
•5. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
•6. Expected survival time ≥ 3 months;
•7. Karnofsky score ≥70;
•8. Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
•9. Liver function:Serum bilirubin (SB) level:≤ normal upper limit（ULN）2 times; aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ ULN 2.5times; or ≤ ULN 5times if Liver metastases are present;
•10. Renal function: Serum creatinine ≤ ULN 1.5times;
+3 more criteria

Exclusion Criteria

•1. Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
•2. Previously received anthracycline-based regimen: the cumulative dose of doxorubicin at or above 500 mg / m2 or the cumulative dose of epirubicin reached or exceeded 800 mg / m2;
•3. The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
•4. Patients with CNS disorders or CNS metastases;
•5. Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
•6. Received any other test drug treatment within 30 days of the first chemotherapy administration;
•7. Pregnant or lactating women;
•8. Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism;
•9. History of aneurysm;
•10. Neurological disorders with a history of epilepsy or ataxia require treatment;
+4 more criteria

Locations (1)

Zhejiang Cancer Hospital

Zhejiang, China

Key Dates

Start Date

March 6, 2017

Primary Completion Date

December 31, 2018

Completion Date

December 31, 2019

Last Updated

January 3, 2018

Enrollment

ESTIMATED participants

Conditions

Poorly Differentiated Thyroid Carcinoma

Interventions

PLD

DRUG

Cisplatin

DRUG

Contacts

jiandong nie, doctor

CONTACT

0311-66575708 niejd@mail.ecspc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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