Actively Recruiting
A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2023-07-25
360
Participants Needed
19
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Anlotinib capsules in patients with advanced medullary thyroid carcinoma to observe its effectiveness and safety in a broad patient population. This real-world study aims to summarize treatment experiences and outcomes for this type of thyroid cancer, focusing on patients with inoperable locally advanced or metastatic disease. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and is classified as a phase 4 clinical trial. The study includes two groups: one receiving Anlotinib capsules at a dose of 12 mg once daily for 2 weeks followed by a 1-week break, repeating every 21 days; and an observational group that collects data from patients who do not receive Anlotinib or similar small-molecule antivascular inhibitors. The study will prospectively and retrospectively gather information about these patients' treatment and outcomes. Participants will be monitored for up to three years, with assessments including overall response rate and progression-free survival as primary outcomes. Secondary outcomes include disease control rate, duration of response, overall survival, and adverse event rates. Patients will undergo regular evaluations of tumor lesions, organ function, and safety monitoring throughout the study period to provide comprehensive data on treatment experiences and outcomes.
CONDITIONS
Brief Title
Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily joined the study, signed the informed consent, and had good compliance
- Patients 18 years of age or older at the time of signing the informed consent
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 to 2
- Expected survival of more than 3 months
- Pathologically confirmed inoperable locally advanced or metastatic medullary thyroid carcinoma with imaging or clinical evidence of disease progression within 14 months of enrollment
- At least one measurable lesion assessed by RECIST 1.1
- Major organ functions within specified limits within 7 days prior to treatment, including hemoglobin ≥85 g/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥80×10⁹/L
- Biochemical exam limits: total bilirubin ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN (or ≤5×ULN if liver metastasis present); serum creatinine ≤1.5×ULN or creatinine clearance rate ≥60 ml/min
- Female patients of reproductive age must agree to use effective birth control during the study and for six months after completion
- Negative serum pregnancy test within 7 days prior to enrollment, and must be non-lactating
- Male patients must agree to use contraception during the study and for six months after study end
You will not qualify if you...
- Patients with other malignancies within the past 3 years, except those with continuous 5-year disease-free survival after single operation or certain low-risk cancers
- Major surgery, open biopsy, or significant trauma within 28 days before treatment start
- Severe or uncontrolled diseases including grade 2 or higher myocardial ischemia, myocardial infarction, arrhythmia, congestive heart failure (NYHA class ≥2)
- Active or uncontrolled severe infection (grade 2 or higher by CTCAE)
- Renal failure requiring dialysis
- Patients with concomitant diseases or conditions judged to seriously endanger safety or interfere with study completion
- Previous use of 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
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 receive Anlotinib capsules: 12 mg once daily for 2 weeks, followed by 1 week off, repeated in 21-day cycles.
Visits every 3 weeks for dosing and assessments
Duration - Up to 3 years
Participants who do not receive Anlotinib capsules are observed with prospective and retrospective data collection.
Visit schedule varies depending on clinical follow-up
Trial Site Locations
Total: 19 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Not Yet Recruiting
2
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
3
Gansu Cancer Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
4
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
The First Affiliated Hospital of Hebei North University
Shijiazhuang, Hebei, China, 050051
Actively Recruiting
6
Tianjin Cancer Hospital
Tianjin, Hebei, China, 300181
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
9
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
10
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
11
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
12
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
13
Jiangsu North People's Hospital
Yangzhou, Jiangsu, China, 225003
Actively Recruiting
14
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110801
Actively Recruiting
15
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
16
Shanxi Provincial Tumor Hospital
Xi’an, Shanxi, China, 710065
Not Yet Recruiting
17
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300122
Actively Recruiting
18
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
19
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 314408
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here