This is an open-label, single-arm, phase II, multi-center clinical trial. Subjects can only enter this study after they meet the inclusion and exclusion criteria. All enrolled patients will receive the treatment with anti-PD-1 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and anti-PD-1 for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
anti-PD-1: 200mg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and anti-PD-1 for up to 2 years. Other Name: Programmed cell death 1 antibody
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Objective 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: up to 2 years
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: up to 2 years
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: up to 2 years
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: up to 2 years
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 progressive disease(PD) or for any cause of death.
Time frame: up to 2 years
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