Evaluating Anlotinib for Advanced Medullary Thyroid Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Tongren Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Gansu Cancer Hospital
  Lanzhou, Gansu, China 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Anlotinib Plus PD-1 Inhibitor vs PD-1 Inhibitor Alone After Chemoimmunotherapy in Advanced ESCC

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• First-line combo therapy with anlotinib, benmelstobart, and HAIC for unresectable HCC

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• Anlotinib plus Bemocizumab as neoadjuvant therapy for ESCC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.