Differentiated Thyroid Cancer
Conditions
Brief summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer.
Interventions
DRUGAnlotinib
Anlotinib p.o. qd
DRUGPlacebo
Placebo p.o. qd
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent 2. Histological documentation of Differentiated Thyroid Cancer ,With measurable disease (using RECIST1.1) 3. ECOG PS:0-1,Life expectancy of more than 6 months 4. Subjects must be 131I-refractory / resistant as defined by at least one of the following: * Lesions that do not demonstrate iodine uptake on any radioiodine scan * Cumulative activity of 131I of \>600 mCi or 22 gigabequerels (GBq) * Lesion that demonstrate iodine uptake on any radioiodine scan,but has progressed by RECIST 1.1 within 18 months of 131I therapy 5. main organs function is normal
Exclusion criteria
1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.) 2. Subjects received radiotherapy external exposure or 131I within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study 3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \] 4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin 5. Patients with factors that could affect oral medication (such as dysphagia etc.) 6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\]) 7. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 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) | To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months) | To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo. |
Countries
China
Outcome results
None listed