Trial Title:
Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
NCT ID:
NCT05830500
Condition:
Medullary Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib Hydrochloride Capsule
Description:
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both
tumor angiogenesis and tumor cell proliferation simultaneously.
Arm group label:
Anlotinib capsules
Summary:
This is a real world study aiming to observe the efficacy and safety of Anlotinib
capsules in patients with advanced medullary thyroid carcinoma, and to summarize the
treatment experience in a broad population of patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients voluntarily joined the study, signed the informed consent, and had good
compliance;
- Patients ≥18 years of age (at the time of signing the informed consent); Eastern
Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected
survival of more than 3 months;
- Patients were pathologically confirmed as inoperable locally advanced or metastatic
medullary thyroid carcinoma (MTC), possessing imaging or clinical evidence of
disease progression within the first 14 months of enrollment;
- Having at least one measurable lesion (assessed by Response Evaluation Criteria In
Solid Tumors (RECIST) 1.1);
- Major organ functions meet the following criteria within 7 days prior to the
treatment:
1. Blood routine examination shall meet the following standards (no transfusion
within 14 days) :
1. Hemoglobin (Hb) ≥85g/L;
2. Absolute Neutrophil Count (ANC) ≥1.5×109/L;
3. Platelet (PLT) ≥80×109/L；
2. Biochemical examination shall meet the following standards:
1. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
2. Alanine transferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN; If
accompanied by liver metastasis, ALT and AST ≤5×ULN；
3. Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance rate (CCr)
≥60ml/min；
- Female patients of reproductive age should agree that birth control (such as
intrauterine device, birth control pills, or condoms) must be used during the study
period until six months after completion; Having a negative serum pregnancy test
within 7 days prior to study enrollment, and must be non-lactating; Male patients
should agree to use contraception during the study period until six months after the
end of the study.
Exclusion Criteria:
- Complicated diseases and history:
1. Patients currently have or had other malignancies within 3 years. Patients with
the following two conditions can be included in the group: Continuous 5-year
disease-free survival (DFS) was achieved for other malignancies treated with a
single operation. Cured cervical carcinoma in situ, non-melanoma skin cancer,
and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in
situ) and T1 (the tumor infiltrates the basal membrane)];
2. Major surgical treatment, open biopsy, or significant traumatic injury were
received within 28 days before the beginning of the treatment;
3. Subjects with any severe and/or uncontrolled disease, including:
1. Having ≥ grade 2 myocardial ischemia or myocardial infarction or
arrhythmia (including QTc ≥450ms (male), QTc ≥470ms (female) and ≥ grade 2
congestive heart failure (classified by New York heart association,
NYHA));
2. Active or uncontrolled severe infection (≥ Common Terminology Criteria for
Adverse Events (CTC AE) 2 grade of infection);
3. Renal failure requiring hemodialysis or peritoneal dialysis;
- Patients with concomitant diseases that, in the investigator's judgment, may
seriously endanger patients' safety or may interfere with the completion of the
study, or are deemed unsuitable for inclusion for other reasons.
- Patients who have previously used anlotinib hydrochloride capsules or similar
Vascular Endothelial Growth Factor- Tyrosine Kinase Inhibitor (VEGFR-TKI) small
molecule drugs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib,
etc.;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shengying Wang, PhD
Phone:
+86 18963790387
Facility:
Name:
Beijing Tongren Hospital Affiliated to Capital Medical University
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohong Chen
Phone:
+86 13911071002
Facility:
Name:
Gansu Cancer Hospital
Address:
City:
Lanzhou
Zip:
730050
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Wang, PhD
Phone:
+86 13893338170
Facility:
Name:
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Xu, PhD
Phone:
+86 13978611163
Email:
1597280804@qq.com
Facility:
Name:
The First Affiliated Hospital of Hebei North University
Address:
City:
Shijiazhuang
Zip:
050051
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoling Shang, PhD
Phone:
+86 15530396553
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangqian Zheng, PhD
Phone:
+86 18622220506
Email:
xiangqian_zheng@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianwu Qin, PhD
Phone:
+86 13598802366
Email:
qinjianwu62@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinguang Qiu, PhD
Phone:
+86 13803710710
Email:
qxg2000@126.com
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingrui Li, PhD
Phone:
+86 13507150698
Email:
Lixingrui07@gmail.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Youhua Zhu, PhD
Phone:
+86 13098899772
Email:
453110015@qq.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jie Chen, PhD
Phone:
+86 13607431251
Email:
446777708@qq.com
Facility:
Name:
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianfeng Sang, PhD
Phone:
+86 13382033138
Email:
32582999@qq.com
Facility:
Name:
Jiangsu North People's Hospital
Address:
City:
Yangzhou
Zip:
225003
Country:
China
Status:
Recruiting
Contact:
Last name:
Haizhong Zhou, PhD
Phone:
+86 18051062358
Email:
475469305@qq.com
Facility:
Name:
Liaoning Cancer Hospital and Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhendong Li, PhD
Phone:
+86 18900917937
Email:
1349946150@qq.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Shaoqiang Zhang, PhD
Phone:
+86 18991232178
Email:
entsqzhang@163.com
Facility:
Name:
Shanxi Provincial Tumor Hospital
Address:
City:
Xi'an
Zip:
710065
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuan An, PhD
Phone:
+86 15389233663
Facility:
Name:
Tianjin People's Hospital
Address:
City:
Tianjin
Zip:
300122
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Gao, PhD
Phone:
+ 86 18622221110
Email:
gaoming68@aliyun.com
Facility:
Name:
The First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Zip:
650032
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruochuan Cheng, PhD
Phone:
+ 86 13708467986
Email:
cruochuan@foxmail.com
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Zip:
314408
Country:
China
Status:
Recruiting
Contact:
Last name:
Minghua Ge, PhD
Phone:
+86 13605813782
Email:
gemingh@163.com
Start date:
June 19, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830500
