Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radi… (NCT05994365) | Clinical Trial Compass
RecruitingNot Applicable
Study of Anlotinib Hydrochloride Capsules in the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma
China380 participantsStarted 2023-08
Plain-language summary
The study aims to observe and investigate the efficacy and safety of Anlotinib capsules in patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma in the real world, and to summarize the treatment experience in a broad population.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Lesions were not iodine-avid: no RAI uptake was confirmed after RAI scan in the presence of a low-iodine diet, adequate thyroid stimulating hormone (TSH) elevation (≥ 30 mIU/L). The definition of no iodine uptake:
✓. no iodine uptake initially;
✓. exist of iodine uptake initially while lost subsequently;
✓. partially uptake;
✓. progression disease despite iodine uptake.
✓. The cumulative dose of RAI was ≥ 600 mCi or 22 GBq, with an interval of at least 3 months.
✓. Radiographically documented disease progression within 18 months of RAI therapy despite the presence of iodine-131 affinity at the time of RAI therapy;
✓. Blood routine test criteria (14 days without blood transfusion):
Exclusion criteria
✕. A history of or concurrent with other malignancies within the past 3 years. Patients were eligible if they had disease-free survival (DFS) for 5 consecutive years in other malignancies treated by single surgery; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
✕. Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of study treatment;
✕. Subjects with any severe and/or uncontrolled illness, 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 IDNCT05994365
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.