Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to VEGFR, FGFR, PDGFR and c-Kit. This study intends to assess the efficacy and safety of anlotinib combined with platinum/gemcitabine for first line treatment of advanced urothelial carcinoma.
The primary objective is to determine the antitumor activity of anlotinib combined with platinum/gemcitabine (Objective Response rate, ORR) in patients with advanced urothelial carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Anlotinib(12mg) oral daily for days 1-14, 21 days per cycle
Cisplatin (70 mg/m2) IV day 1
If the patients can't tolerate cisplatin, they will be treated with carboplatin (AUC 4.5mg/mL·min) IV day 1
Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Tianjin Medical Unversity Second Hospital
Tianjin, China
Objective Response Rate (ORR)
The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (\>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From date of enrollment until disease progression,assessed up to 1 year
Duration of Response (DoR)
The duration of response (CR or PR) is defined as the earliest date a participant achieved a CR or a PR, calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
Time frame: From date of enrollment until disease progression,assessed up to 3 years
Progression free survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Time frame: From date of enrollment until the date of first documented progression,assessed up to 3 years
Overall Survival (OS)
Overall survival is defined as the time interval in days between the date of the first dose of study drug and the participant's death from any cause.
Time frame: From date of enrollment until death,assessed up to 5 years
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