This is a prospective, multicenter, phase II study designed to evaluate the efficacy and safety of disitamab vedotin combined with platinum plus bevacizumab as first-line therapy for HER2-expressing, HRD-negative high-risk ovarian cancer. Forty-three patients with pathologically confirmed HRD-negative high-risk ovarian cancer will be enrolled. After enrollment, patients will receive disitamab vedotin plus platinum and bevacizumab as first-line and maintenance treatment. First-line phase: Carboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h ,Bevacizumab 7.5-15 mg/kg intravenously on Day 1 every 21 days over 30-90 min. Maintenance phase: Patients who achieve response (CR or PR) will continue disitamab vedotin monotherapy plus bevacizumab (investigator decides whether to continue disitamab vedotin and for how long). Maintenance duration: bevacizumab until disease progression or up to 22 cycles; disitamab vedotin up to 6 months (8 cycles).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
First-line phase:Carboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h; Bevacizumab 7.5-15 mg/kg intravenously on Day 1 every 21 days over 30-90 min. Maintenance phase:Patients who achieve response (CR or PR) will continue disitamab vedotin monotherapy plus bevacizumab (investigator decides whether to continue disitamab vedotin and for how long). Maintenance duration: bevacizumab until disease progression or up to 22 cycles; disitamab vedotin up to 6 months (8 cycles).
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGJiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGProgression-Free Survival (PFS)
From enrollment until documented disease progression or death from any cause, whichever occurs first.
Time frame: From enrollment until 16 months
Objective Response Rate (ORR)
Disease Control Rate (DCR) is defined as the proportion of patients who achieve a Best Overall Response of PR or CR .
Time frame: up to 24 weeks
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients who achieve a Best Overall Response of PR or CR or SD.
Time frame: up to 24 weeks
overall survival(OS)
From enrollment until death from any cause.
Time frame: Up to 5 years
Incidents of Adverse Events
All patients who receive at least one dose of any study drug are included in the safety-analysis set.
Time frame: 30 days after the end of treatment
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