Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma (NCT05830500) | Clinical Trial Compass
RecruitingPhase 4
Study of Anlotinib in Patients With Advanced Medullary Thyroid Carcinoma
China360 participantsStarted 2023-06-19
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Blood routine examination shall meet the following standards (no transfusion within 14 days) :
✕. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (the tumor infiltrates the basal membrane)\];
✕. Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;
✕. Subjects with any severe and/or uncontrolled disease, including:
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Baseline up to 3 years.
2
Progression-free Survival (PFS)
Timeframe: Baseline up to 3 years.
Trial details
NCT IDNCT05830500
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. 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;