Actively Recruiting
Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2023-08-16
380
Participants Needed
3
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participate in this study, sign the informed consent form and had good compliance
- Aged 18 to 70 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1
- Expected survival of more than 6 months
- Histopathologically confirmed locally advanced or metastatic differentiated thyroid cancer with radiographically documented disease progression within 18 months without radioactive iodine therapy
- Meet at least one of the following: lesions not iodine-avid, cumulative radioactive iodine dose of 600 mCi or more with at least 3 months interval, or disease progression within 18 months of radioactive iodine therapy despite iodine affinity
- At least one measurable lesion according to RECIST 1.1
- Major organ functions meet specified blood and biochemical criteria within 7 days prior to treatment
- Females of childbearing potential agree to use contraception during the study and 6 months after, have a negative pregnancy test within 7 days before enrollment, and are non-lactating
- Males agree to use contraception during the study and 6 months after
You will not qualify if you...
- History of or concurrent other malignancies within the past 3 years, except certain cured cancers and superficial tumors
- Major surgery, open biopsy, or significant traumatic injury within 28 days before study treatment
- Severe or uncontrolled illnesses including grade 2 or higher myocardial ischemia or infarction, arrhythmia, congestive heart failure, severe infections, or renal failure requiring dialysis
- Conditions that endanger patient safety or affect study completion as judged by investigators
- Previous treatment with Anlotinib hydrochloride capsules or similar VEGFR-TKI small molecule drugs such as vandetanib, cabozantinib, lenvatinib, sunitinib, or sorafenib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100007
Actively Recruiting
2
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300122
Actively Recruiting
3
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300181
Actively Recruiting
Research Team
M
Ming Gao, PhD
CONTACT
Y
Yansong Lin, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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