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.
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;
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) );
Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma Patients
Cohort
Prospective
Anlotinib Hydrochloride Capsule
DrugAnlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation.
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Progression-free Survival (PFS)
From the first dose to the date of objective disease progression or death, whichever occurs first.
Disease-control Rate (DCR)
The proportion of subjects response of CR, PR, or stable disease (SD), subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks.
Duration of Response (DOR)
From the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first.
Overall Survival (OS)
From randomization to the time of death from any cause.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
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