Actively Recruiting
A Real-world Study of Anlotinib Hydrochloride Capsules in Treating 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
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of Anlotinib capsules for patients with locally advanced or metastatic differentiated thyroid cancer that no longer responds to radioactive iodine treatment. This real-world study aims to evaluate how well Anlotinib works and its safety in a broad patient population over time. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group and includes patients aged 18 to 75 years. Participants receiving Anlotinib will take 12 mg of the capsules once daily for two weeks, followed by a one-week break, in repeating 21-day cycles. Another group will be observed and their data collected without receiving Anlotinib or similar small-molecule antivascular drugs. The study will continue to collect data prospectively and retrospectively, comparing outcomes between those treated with Anlotinib and those who are not. During the study, researchers will monitor participants for up to three years, assessing measures such as overall response rate, progression-free survival, disease control rate, duration of response, overall survival, and adverse events. Data collection will include medical evaluations, imaging, and laboratory tests to understand treatment effects and safety. Participants will be closely followed throughout the study to document their health and treatment experiences.
CONDITIONS
Brief 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 have 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
- Radiographically documented disease progression within 18 months without radioactive iodine therapy
- Meet at least one of these criteria:
- Lesions show no or partial iodine uptake or progression despite iodine uptake
- Received cumulative radioactive iodine dose of 600 mCi or more with at least 3 months interval
- Disease progression within 18 months of radioactive iodine therapy despite iodine affinity
- At least one measurable lesion per RECIST 1.1 criteria
- Major organ functions meet specific blood and biochemical test criteria within 7 days prior to treatment
- Females of childbearing potential agree to use contraception during study and 6 months after, have negative pregnancy test, and are non-lactating
- Males agree to use contraception during study and 6 months after
You will not qualify if you...
- History or presence of other malignancies within past 3 years, except certain treated cancers with long disease-free survival
- Major surgery, open biopsy, or significant injury within 28 days before study treatment
- Severe or uncontrolled illnesses including:
- Grade 2 or higher myocardial ischemia, infarction, arrhythmia, or congestive heart failure
- Severe active or uncontrolled infections
- Renal failure requiring dialysis
- Any concomitant disease that endangers patient safety or study completion
- Prior treatment with Anlotinib or similar VEGFR-TKI drugs such as vandetanib, Cabozantinib, lenvatinib, sunitinib, or sorafenib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants in the Anlotinib group take Anlotinib hydrochloride capsules daily for 2 weeks followed by 1 week off, in repeating 21-day cycles.
Visits scheduled according to treatment cycles
Duration - Up to 3 years
Participants in the observation group are monitored without receiving Anlotinib, with data collected prospectively or retrospectively.
Visit schedule varies based on routine clinical care
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
Y
Yansong Lin, PhD
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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