PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma (NCT03387943) | Clinical Trial Compass
UnknownPhase 2
PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
China30 participantsStarted 2017-03-06
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Volunteer to participate and sign the informed consent form;
✕. Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
✕. 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;
✕. The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
✕. Patients with CNS disorders or CNS metastases;
✕. Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
What they're measuring
1
disease control rate(DCR)
Timeframe: disease control rate will be evaluated every 2 cycles (each cycle is 21 days) from date of administration of drugs until the date of first documented progression，up to 18 months.
✕. Received any other test drug treatment within 30 days of the first chemotherapy administration;
✕. Pregnant or lactating women;
✕. Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism;