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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 2

Conditions: Poorly Differentiated Thyroid Carcinoma

Treatments: Drug: PLD; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03387943

CSPC-DMS-CG-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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;
11. LVEF ≥ 50%;
12. No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever > 38℃;
13. Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.

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;
11. A history of drug abuse and incapable of abstinence or mental disorder;
12. A history of peripheral neuropathy and the muscle strength is below level 3;
13. Suffering from other diseases and complications of hand-foot syndrome;
14. Researchers think it is not suitable for enrolling.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PLD plus Cisplatin

Experimental group

Description:

liposomal doxorubicin(PLD) 35 mg/m2,iv,d1, plus cisplatin 75 mg/m2,drip,d1-3, once every 21days, for 6 cycles, to progression or intolerance.

Treatment:

Drug: Cisplatin

Drug: PLD