NCT05830500 Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
| NCT ID | NCT05830500 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Condition | Medullary Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-06-19 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 360 participants in total. It began in 2023-06-19 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.;
Frequently Asked Questions
Who can join the NCT05830500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Medullary Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05830500 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05830500 currently recruiting?
Yes, NCT05830500 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chia Tai Tianqing Pharmaceutical Group Co., Ltd. to inquire about joining.
Where is the NCT05830500 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Lanzhou, China, Nanning, China and 11 additional locations.
Who is sponsoring the NCT05830500 clinical trial?
NCT05830500 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. The trial plans to enroll 360 participants.
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