This study aims to demonstrate that, in subjects with locally advanced or metastatic iodine - refractory differentiated thyroid cancer who have failed previous VEGFR - targeted therapy, AL2846 can significantly prolong progression - free survival (PFS) compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
AL2846 Capsule is a multi - target tyrosine kinase inhibitor, which has significant inhibitory effects on c-Mesenchymal-epithelial transition factor (c - MET), stem cell factor receptor (c - KIT), VEGFR1 and Ret Proto-Oncogene (RET).
AL2846 Placebo without drug substance.
Progression - Free Survival (PFS) evaluated by the Independent Review Committee (IRC)
Defined as the time from the date of randomization to the date of disease progression determined by IRC or death, whichever occurred firstly.
Time frame: 34 months
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death for any reason.
Time frame: 34 months
Compare the Progression - Free Survival (PFS) evaluated by the researchers in the treatment group and the placebo group
PFS: The time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time frame: 34 months
Compare the objective response rate (ORR) between the treatment group and the placebo group
Objective Response Rate (ORR): It is defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC)/investigator according to RECIST 1.1.
Time frame: 34 months
Compare the Disease Control Rate (DCR) between the treatment group and the placebo group
Disease Control Rate (DCR): It is defined as the percentage of subjects with complete response (CR), partial response (PR), or stable disease (SD) as determined by the Independent Review Committee (IRC)/investigator according to RECIST 1.1.
Time frame: 34 months
Compare the Duration of Response (DOR) between the treatment group and the placebo group
Duration of Response (DOR): It is defined as the time from the first documented and confirmed objective response to disease progression or death from any cause (whichever occurs first), as determined by the IRC/investigator according to RECIST v1.1.
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The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGcancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Guilin Medical University
Gui'lin, Guangxi, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital Of GXUST
Liuchow, Guangxi, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Hainan Medical University
Hainan, Haikou, China
NOT_YET_RECRUITINGCangZhou Center Hospital
Cangzhou, Hebei, China
NOT_YET_RECRUITING...and 25 more locations
Time frame: 34 months
Evaluate the safety of AL2846 capsules compared with placebo in subjects with locally advanced or metastatic iodine - refractory differentiated thyroid cancer who have failed previous VEGFR - targeted therapy
The incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 grading scale.
Time frame: 34 months