Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Subjects who received Anlotinib will not be eligible for the open-label phase. |
|
| Placebo | Placebo Comparator | Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib p.o. qd |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo. | Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo. | Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months) |
Not provided
Inclusion Criteria:
Signed and dated informed consent
Histological documentation of Differentiated Thyroid Cancer ,With measurable disease (using RECIST1.1)
ECOG PS:0-1,Life expectancy of more than 6 months
Subjects must be 131I-refractory / resistant as defined by at least one of the following:
main organs function is normal
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo p.o. qd |
|
| Beijing Tongren Hospital |
| Beijing |
| Beijing Municipality |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 404100 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | China |
| Gansu Province Tumor Hospital | Lanzhou | Gansu | China |
| Sun Yat-Sen University Cancer Center | Guozhou | Guangdong | China |
| Harbin medical university affiliated tumor hospital | Harbin | Heilongjiang | China |
| Henan Province Tumor Hospital | Luoyan | Henan | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hunan Province Tumor Hospital | Changsha | Hunan | China |
| Jiangsu province tumor hospital | Nanjing | Jiangsu | China |
| Jilin Cancer Hospital | Changchun | Jilin | China |
| Liaoning Province Tumor Hospital | Shenyang | Liaoning | China |
| Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| West China Hospital Of Sichuan University | Chongqing | Sichuan | 400010 | China |
| 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital . | Tianjin | Tianjin Municipality | 300600 | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| ID | Term |
|---|---|
| C000625192 | anlotinib |
Not provided
Not provided
Not provided