Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
386
A multi-target receptor tyrosine kinase inhibitor.
Anlotinib blank analog capsule.
Paclitaxel 175 mg/m\^2 IV on Day 1 of each 21-day cycle.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Progression Free Survival (PFS) evaluated by IRC
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
Time frame: up to 24 months
Progression Free Survival (PFS) evaluated by investigator
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 24 months
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 24 months
Overall Response Rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 24 months
Disease Control Rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 24 months
Duration of Overall Response (DOR)
The time when the patient first achieved complete or partial remission to disease progression.
Time frame: up to 24 months
PFS rate at month 6
The percentage of PFS at month 6.
Time frame: up to 6 months
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Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
PFS rate at month 12
The percentage of PFS at month 12.
Time frame: up to 12 months
OS rate at month 6
The percentage of OS at month 6.
Time frame: up to 6 months
OS rate at month 12
The percentage of OS at month 12.
Time frame: up to 12 months
OS rate at month 18
The percentage of OS at month 18.
Time frame: up to 18 months
Adverse Event (AE)
Safety data
Time frame: up to 24 months
Serious Adverse Event (SAE)
Safety data
Time frame: up to 24 months
Abnormal laboratory test index
Safety data
Time frame: up to 24 months