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New treatment option for Medullary Thyroid Cancer
Official title Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
ClinicalTrials.gov ID: NCT05830500
What this study is testing
What is Anlotinib Hydrochloride Capsule?
Anlotinib Hydrochloride Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for medullary thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Patients were pathologically confirmed as inoperable locally advanced or metastatic medullary thyroid carcinoma (MTC), possessing imaging or clinical...
- 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:
You likely can't join if
- Complicated diseases and history:
- Patients currently have or had other malignancies within 3 years. Patients with the following two conditions can be included in the group: Continuous...
- Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;
- people with any severe and/or uncontrolled disease, including:
- Having ≥ grade 2 myocardial ischemia or myocardial infarction or arrhythmia (including QTc ≥450ms (male), QTc ≥470ms (female) and ≥ grade 2...
- Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection);
See the full eligibility 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...
- 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:
- Blood routine examination shall meet the following standards (no transfusion within 14 days) :
- Hemoglobin (Hb) ≥85g/L;
- Absolute Neutrophil Count (ANC) ≥1.5×109/L;
- Platelet (PLT) ≥80×109/L；
- Biochemical examination shall meet the following standards:
- Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
- Alanine transferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST ≤5×ULN；
- 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...
- Complicated diseases and history:
- 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...
- Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;
- people with any severe and/or uncontrolled disease, including:
- 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));
- Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection);
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Lanzhou, Gansu, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Tianjin, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Yangzhou, Jiangsu, China
- Shenyang, Liaoning, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Lanzhou, Gansu, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China; Tianjin, Hebei, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.