The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel) and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGobjective response rate
Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR
Time frame: Assessed at the end of 6 cycle(each cycle is 21 days)
6-month progression-free survival rate
the percentage of participants with no progression event at 6 months after starting study treatment
Time frame: assessed up to 6 months
progression-free survival
PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first
Time frame: up to 3 years
overall survival
Overall survival is defined as the time from treatment start until death from any cause
Time frame: assessed up to 3 years
Disease control rate
the percentage of complete and partial response as well as stable disease
Time frame: Assessed at the end of 6 cycle(each cycle is 21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.