Clinical trial · Interventional
PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
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
NCT03387943CI-TRIAL-00031007unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Poorly Differentiated Thyroid Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| PLD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PLD plus Cisplatin
- 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.
- interventionNames
- Drug: PLD
- Drug: Cisplatin
Primary outcomes (1)
- 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.
- description
- the rate of CR,PR and SD
Secondary outcomes (4)
- measure
- OS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.