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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Cisplatin

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.