Clinical trial NCT03387943: PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Poorly Differentiated Thyroid Carcinoma
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause,assessed up to 18 months.
measure: PFS
timeFrame: From date of randomization until the date of first documented disease progression or date of death from any case,whichever came first,assessed up to 18 months.
measure: Incidence of adverse events assessed by number and severity of adverse event in the treatment.
timeFrame: A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 18 months.
measure: quality of life assessment
timeFrame: It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
Study officials:
affiliation: Zhejiang Cancer Hospital
name: minghua ge, doctor
role: PRINCIPAL_INVESTIGATOR
References: