About this trial
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population.
Eligibility criteria
Qualifiers
Patients voluntarily participate in this study, sign the informed consent form and had good compliance;
Aged 18 ~ 70 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; more than 6 months of expected survival ;
Histopathologically confirmed locally advanced or metastatic differentiated thyroid cancer, radiographically documented disease progression within 18 months of absence of radioactive iodine (RAI) therapy;
no iodine uptake initially;
Disqualifiers
A history of or concurrent with other malignancies within the past 3 years. Patients were eligible if they had disease-free survival (DFS) for 5 consecutive years in other malignancies treated by single surgery; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of study treatment;
Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including Corrected QT Interval (QTc)≥450ms(male), QTc≥ 470ms(female)) and ≥ grade 2 congestive heart failure (NYHA classification);
Severe active or uncontrolled infection (≥ grade 2 infection according to Common Terminology Criteria for Adverse Events (CTCAE) );
Trial design
Treatments tested in this trial
- Anlotinib Hydrochloride Capsule