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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anlotinib + RAI | Experimental | Patients in this arm will receive anlotinib 6 cycles around RAI treatment ( 4 cycles before and 2 cycles after RAI) |
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| RAI only | Other | Patients in this arm will receive RAI treatment as scheduled. |
|
| Penpulimab + RAI | Experimental | Patients in this arm will receive Penpulimab from one week prior to RAI treatment until the disease progressed or intolerable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride | Drug | Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | Proportion of patients with target lesions reaching PR or CR | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Proportion of patients with target lesions reaching PR, CR or SD | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yansong Lin, MD | Contact | +86-10-69155610 | linys@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yansong Lin, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000614965 | Iodine-131 |
| C000720860 | penpulimab |
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| Sodium Iodide I 131 | Drug | RAI treatment may shrink the tumor |
|
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| Penpulimab | Drug | Penpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC. |
|
| 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 | up to 24 months |
| Nuclear medicine functional imaging changes of target lesions | The dynamic changes of I uptake and 18F-FDG PET/CT imaging | up to 24 months |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |