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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake.
RAI treatment may shrink the tumor
Penpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGobjective response rate (ORR)
Proportion of patients with target lesions reaching PR or CR
Time frame: up to 24 months
Disease Control Rate (DCR)
Proportion of patients with target lesions reaching PR, CR or SD
Time frame: up to 24 months
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
Time frame: up to 24 months
Progression-free Survival (PFS) (median)
PFS 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
Time frame: up to 24 months
Nuclear medicine functional imaging changes of target lesions
The dynamic changes of I uptake and 18F-FDG PET/CT imaging
Time frame: up to 24 months
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