Evaluating Anlotinib for Advanced Medullary Thyroid Cancer

A Real World Study of Anlotinib for Patients With Advanced Medullary Thyroid Carcinoma

This study is testing whether Anlotinib can help people with advanced medullary thyroid cancer feel better and manage their disease more effectively.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: anlotinib, cabozantinib, lenvatinib, sunitinib
• Locations: 19 sites (Hefei, Anhui and 18 other locations)
• Trial ID: NCT05830500 on ClinicalTrials.gov

What this trial studies

This study aims to observe the efficacy and safety of Anlotinib capsules in patients with advanced medullary thyroid carcinoma. It focuses on gathering real-world data to summarize treatment experiences among a diverse patient population. Participants will be monitored for disease progression and treatment response using established evaluation criteria. The study is designed to provide insights into the effectiveness of Anlotinib in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with inoperable locally advanced or metastatic medullary thyroid carcinoma and measurable disease progression.

Not a fit: Patients with early-stage medullary thyroid carcinoma or those who have not shown disease progression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced medullary thyroid carcinoma.

How similar studies have performed: Other studies have explored targeted therapies for medullary thyroid carcinoma, but the specific use of Anlotinib in this context is less common, making this approach somewhat novel.

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.;

Where this trial is running

Hefei, Anhui and 18 other locations

• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Tongren Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Gansu Cancer Hospital — Lanzhou, Gansu, China (Recruiting)
• Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University) — Nanning, Guangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Hebei North University — Shijiazhuang, Hebei, China (Recruiting)
• Tianjin Cancer Hospital — Tianjin, Hebei, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
• Jiangsu North People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
• Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• Shanxi Provincial Tumor Hospital — Xi’an, Shanxi, China (Not_yet_recruiting)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Conditions Medullary Thyroid Cancer