Status:
UNKNOWN
PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Poorly Differentiated Thyroid Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
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 21day...
Eligibility Criteria
Inclusion
- Volunteer to participate and sign the informed consent form;
- Age :18-70 years old;
- Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
- Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
- At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
- Expected survival time ≥ 3 months;
- Karnofsky score ≥70;
- Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
- 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;
- Renal function: Serum creatinine ≤ ULN 1.5times;
- LVEF ≥ 50%;
- No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever \> 38℃;
- Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.
Exclusion
- 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;
- 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;
- History of aneurysm;
- Neurological disorders with a history of epilepsy or ataxia require treatment;
- A history of drug abuse and incapable of abstinence or mental disorder;
- A history of peripheral neuropathy and the muscle strength is below level 3;
- Suffering from other diseases and complications of hand-foot syndrome;
- Researchers think it is not suitable for enrolling.
Key Trial Info
Start Date :
March 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03387943
Start Date
March 6 2017
End Date
December 31 2019
Last Update
January 3 2018
Active Locations (1)
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1
Zhejiang Cancer Hospital
Zhejiang, China