The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PD-1 antibody,Tislelizumab (BGB-A317)
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGProgression-free survival(PFS)
12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
Time frame: 12 months
R0 rate
R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)
Time frame: after interval debulking surgery for one week
CRR
CRR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The CRR will be assessed by a blind independent central reviewer per RECIST 1.1
Time frame: 3 months
PRR
At interval cytoreduction pathologic complete remission rate will be measured using RECIST and immune-related response criteria.
Time frame: 3 months
OS
OS is defined as the time from the date of randomization until death.
Time frame: 5 years
AEs
Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy
Time frame: 3 months
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