The purpose of the study is to evaluate the Efficacy and safety of Anti-PD-1 antibody combined With anlotinib in the treatment of recurrent or advanced endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Anti-PD-1 antibody administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus Anlotinib 12 mg administered orally (PO) once daily (QD) Day1-Day14 during each 21-day cycle.
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate(ORR)
Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR.
Time frame: Approximately 24 months.
Duration of Response(DoR)
Duration of response was defined as the time when the tumor is first evaluated as CR or PR to the first assessment for PD or for any cause of death.
Time frame: Approximately 24 months.
Disease Control Rate(DCR)
Disease control rate was defined as the proportion of subjects with complete response (CR) or partial response (PR) or disease stabilization (SD) in the analyzed population according to the RECIST 1.1 criteria.
Time frame: Approximately 24 months.
Time to Objective Response(TTR)
Time to objective response was defined as the time from the start of treatment to the first objective tumor remission (CR or PR).
Time frame: Approximately 24 months.
Progression Free Survival(PFS)
Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.
Time frame: Approximately 24 months.
Overall Survival(OS)
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time frame: Approximately 48 months.
Overall Survival Rate at 12 months
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Overall survival rate at 12 months was defined as the proportion of patients who were still alive in 12 months.
Time frame: Approximately 12 months.