A Real-world Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.3 sites in 1 country380 target enrollmentAugust 2023

ConditionsThyroid Neoplasms

InterventionsAnlotinib Hydrochloride Capsule

DrugsAnlotinib Hydrochloride Capsule

Overview

Phase: Not Applicable
Intervention: Anlotinib Hydrochloride Capsule
Conditions: Thyroid Neoplasms
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 380
Locations: 3
Primary Endpoint: Overall Response Rate (ORR)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2023

End Date

December 2028

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•Meet any of the following:
•Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH) elevation (≥ 30 mIU/L). The definition of no iodine uptake:
•no iodine uptake initially;
•exist of iodine uptake initially while lost subsequently;
•partially uptake;
•progression disease despite iodine uptake.
•The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months.

Exclusion Criteria

•Comorbidities and medical history:
•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;
•Subjects with any severe and/or uncontrolled illness, including:
•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) );
•Renal failure requiring hemodialysis or peritoneal dialysis;
•Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study, or patients who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators.
•patients with previous treatment with anlotinib hydrochloride capsules or similar vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or sorafenib, etc.;