Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05830500
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Medullary Thyroid Cancer
Arms & Interventions

Arms

Experimental: Anlotinib capsules

Anlotinib: 12 mg once daily for 2 weeks, followed by a discontinuance of 1 week (21-daya as a cycle)

No Intervention: Observation

Observational group: prospectively and retrospectively collect data for patients who did not receive anlotinib hydrochloride capsules or similar small-molecule antivascular inhibitors (including Rearranged during transfection (RET) inhibitors, etc.).

Interventions

Drug: - Anlotinib Hydrochloride Capsule

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Anhui Provincial Cancer Hospital, Hefei 1808722, Anhui 1818058, China

Status

Not yet recruiting

Address

Anhui Provincial Cancer Hospital

Hefei 1808722, Anhui 1818058, 230031

Site Contact

Shengying Wang, PhD

+86 18963790387

Beijing 1816670, Beijing Municipality 2038349, China

Status

Recruiting

Address

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing 1816670, Beijing Municipality 2038349, 100005

Site Contact

Xiaohong Chen

+86 13911071002

Gansu Cancer Hospital, Lanzhou 1804430, Gansu 1810676, China

Status

Recruiting

Address

Gansu Cancer Hospital

Lanzhou 1804430, Gansu 1810676, 730050

Site Contact

Jun Wang, PhD

+86 13893338170

Nanning 1799869, Guangxi 1809867, China

Status

Not yet recruiting

Address

Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)

Nanning 1799869, Guangxi 1809867, 530021

Site Contact

Jian Xu, PhD

[email protected]

+86 13978611163

Shijiazhuang 1795270, Hebei 1808773, China

Status

Recruiting

Address

The First Affiliated Hospital of Hebei North University

Shijiazhuang 1795270, Hebei 1808773, 050051

Site Contact

Xiaoling Shang, PhD

+86 15530396553

Tianjin Cancer Hospital, Tianjin, Hebei 1808773, China

Status

Recruiting

Address

Tianjin Cancer Hospital

Tianjin, Hebei 1808773, 300181

Site Contact

Xiangqian Zheng, PhD

[email protected]

+86 18622220506

Henan Cancer Hospital, Zhengzhou 1784658, Henan 1808520, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou 1784658, Henan 1808520, 450003

Site Contact

Jianwu Qin, PhD

[email protected]

+86 13598802366

Zhengzhou 1784658, Henan 1808520, China

Status

Recruiting

Address

The First Affiliated Hospital of Zhengzhou University

Zhengzhou 1784658, Henan 1808520, 450052

Site Contact

Xinguang Qiu, PhD

[email protected]

+86 13803710710

Wuhan 1791247, Hubei 1806949, China

Status

Recruiting

Address

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan 1791247, Hubei 1806949, 430030

Site Contact

Xingrui Li, PhD

[email protected]

+86 13507150698

Hubei Cancer Hospital, Wuhan 1791247, Hubei 1806949, China

Status

Recruiting

Address

Hubei Cancer Hospital

Wuhan 1791247, Hubei 1806949, 430079

Site Contact

Youhua Zhu, PhD

[email protected]

+86 13098899772

Hunan Cancer Hospital, Changsha 1815577, Hunan 1806691, China

Status

Not yet recruiting

Address

Hunan Cancer Hospital

Changsha 1815577, Hunan 1806691, 410031

Site Contact

Jie Chen, PhD

[email protected]

+86 13607431251

Nanjing 1799962, Jiangsu 1806260, China

Status

Recruiting

Address

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University

Nanjing 1799962, Jiangsu 1806260, 210008

Site Contact

Jianfeng Sang, PhD

[email protected]

+86 13382033138

Jiangsu North People's Hospital, Yangzhou 1787227, Jiangsu 1806260, China

Status

Recruiting

Address

Jiangsu North People's Hospital

Yangzhou 1787227, Jiangsu 1806260, 225003

Site Contact

Haizhong Zhou, PhD

[email protected]

+86 18051062358

Liaoning Cancer Hospital and Institute, Shenyang 2034937, Liaoning 2036115, China

Status

Recruiting

Address

Liaoning Cancer Hospital and Institute

Shenyang 2034937, Liaoning 2036115, 110801

Site Contact

Zhendong Li, PhD

[email protected]

+86 18900917937

Xi’an 11474004, Shanxi 1795912, China

Status

Recruiting

Address

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an 11474004, Shanxi 1795912, 710061

Site Contact

Shaoqiang Zhang, PhD

[email protected]

+86 18991232178

Shanxi Provincial Tumor Hospital, Xi’an 11474004, Shanxi 1795912, China

Status

Not yet recruiting

Address

Shanxi Provincial Tumor Hospital

Xi’an 11474004, Shanxi 1795912, 710065

Site Contact

Yuan An, PhD

+86 15389233663

Tianjin People's Hospital, Tianjin 1792947, Tianjin Municipality 1792943, China

Status

Recruiting

Address

Tianjin People's Hospital

Tianjin 1792947, Tianjin Municipality 1792943, 300122

Site Contact

Ming Gao, PhD

[email protected]

+ 86 18622221110

Kunming 1804651, Yunnan 1785694, China

Status

Recruiting

Address

The First Affiliated Hospital of Kunming Medical University

Kunming 1804651, Yunnan 1785694, 650032

Site Contact

Ruochuan Cheng, PhD

[email protected]

+ 86 13708467986

Zhejiang Provincial People's Hospital, Hangzhou 1808926, Zhejiang 1784764, China

Status

Recruiting

Address

Zhejiang Provincial People's Hospital

Hangzhou 1808926, Zhejiang 1784764, 314408

Site Contact

Minghua Ge, PhD

[email protected]

+86 13605813782

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