Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT04952493
Brief Summary:
The purpose of this study is to assess the efficacy and safety of anlotinib in combination with I-131 in locally advanced/metastatic differentiated thyroid cancer. Anlotinib may stop the growth of tumor cells and improve iodine uptake.
Detailed Description:
Primary Outcome Measures:
objective response rate (ORR)
Secondary Outcome Measures：
1. Biochemical Response Rate (BRR) Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice
2. Disease Control Rate (DCR)
3. Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
4. Nuclear medicine functional imaging changes of target lesions The dynamic changes of I uptake and 18F-FDG PET/CT imaging
Study:
NCT04952493
Study Brief:
Protocol Section:
NCT04952493