Thyroid cancer
Conditions
Interventions
All subjects:Diagnostic dose I-131 whole-body imaging after 4 weeks of pratinib treatment to assess whether pratinib has the ability to enhance I-131 uptake at the lesion and to treat patients who suc
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
12 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 12 years or older with differentiated thyroid cancer with distant metastases; 2. Positive results of RET fusion by designated central laboratory or genetic testing company; 3. The patient has metastatic lesions, the size of which can be determined by CT scan; 4. The patient has received more than one treatment with radioiodine and has a therapeutic dose whole-body imaging result, and there are four scenarios defined as radioiodine resistance in the 2015 ATA guidelines: a. Metastatic lesions without iodine uptake at initial treatment; b. Lesions with iodine uptake at initial treatment that no longer uptake iodine during treatment follow-up; c. Lesions with iodine uptake in part and lesions without iodine uptake in part d. Lesions with iodine uptake but progression after treatment with iodine-131; 5. ECOG 0-1 points; 6. Expected survival = 12 months; 7. Willing and able to comply with the study protocol, including follow-up and examination; 8. Have signed a written informed consent form. Subjects must be able to understand and voluntarily sign a written informed consent form, and signed informed consent must be obtained prior to any trial-specific procedures, and patients under 18 years of age must have a legal representative sign the written informed consent form; 9. Subjects must agree to adequate contraception at the time of sexual intercourse from the time the written informed consent is signed until 6 months after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with selective RET inhibitors; 2. Central nervous system (CNS) metastases or primary CNS tumors associated with progressive neurological symptoms; 3. Uncontrolled cardiovascular disease; 4. QT interval (QTcF) > 470 ms, history of QT prolongation syndrome or family history of QT prolongation syndrome; 5. Clinically symptomatic interstitial lung disease or interstitial pneumonia; 6. Patient has had any of the following within 14 days prior to the first dose of study drug: a. Platelet count 2 x upper limit of normal; e. Creatinine clearance 5.5 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactHuang Rui
West China Hospital, Sichuan University
Outcome results
None listed