Last updated: March 11, 2022
Sponsor: Qianfoshan Hospital
Overall Status: Active - Not Recruiting
Phase
4
Condition
Neoplasm Metastasis
Cancer
Treatment
N/AClinical Study ID
NCT04683575
XYJA2020
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants have signed informed consent forms;
- Patients with differentiated thyroid carcinoma diagnosed pathologically after thyroidsurgery;
- Male or female patients aged 18-75 years;
- Women who are likely to become pregnant must use the appropriate contraceptive methodto avoid pregnancy and minimize the likelihood of conception between the beginning ofthe drug intervention study and the 28th day after the study.
Exclusion
Exclusion Criteria:
- A patient who is pregnant or breastfeeding;
- Currently, hepatase cytochrome P450 3A4 induction or inhibitor therapy, antiviraltherapy for immunodeficiency diseases (note: hepatase induction or inhibitor:phenobarbital phenobarbital sodium rifampicin carbamazepine grisoflomycin anddexamethasone and chloramphenicol allopurinol ketone conazole isoniazid imittidinephenothiazine);
- Gastrointestinal surgery that may affect the study of drug absorption;
- The patient has a history of haemoglobin disease or acute progressive nephropathy orautoimmune skin disease;
- A history of substance abuse and alcohol abuse within the last 1 year;
- There are therapeutic contraindications with selenium yeast capsules as listed in theinstructions;
- New York Heart Association (NYHA) class III or IV congestive heart failure and/or leftventricular ejection fraction of 40% with a significant cardiovascular history in thepast 6 months: myocardial infarction coronary angioplasty or bypass surgery valvulardisease or repair of unstable angina transient ischemic attack or cerebrovascularaccident;
- There are obvious abnormalities in liver function;
- The patient has significant liver disease acute active hepatitis or chronic activehepatitis clinical signs or symptoms;
- Laboratory and physical examination or ECG findings of any clinically significantabnormality would, in the investigator's judgment, compromise the patient's safety orprevent successful participation in the clinical study;
- Patients with severe renal insufficiency.
Study Design
Total Participants: 5000
Study Start date:
May 30, 2022
Estimated Completion Date:
December 31, 2025
Connect with a study center
The First affiliated hospital of Shandong First Medical University
Jinan, Shandong 250000
ChinaSite Not Available

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