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).
Voluntary participation with written informed consent.
Age 18-75 years.
Expected survival ≥ 12 weeks.
Histologically/cytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV).
Non-high-risk histologic sub-types of ovarian carcinoma.
CNS metastases and/or carcinomatous meningitis. -
Requirement for parenteral hydration/nutrition OR clinical/radiologic evidence of partial bowel obstruction or perforation.
≥ Grade-2 peripheral neuropathy. -
Single group
RC48+Carboplatin+Bevacizumab
DrugFirst-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).
Progression-Free Survival (PFS)
From enrollment until documented disease progression or death from any cause, whichever occurs first.
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 .
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.
overall survival（OS）
From enrollment until death from any cause.
Incidents of Adverse Events
All patients who receive at least one dose of any study drug are included in the safety-analysis set.
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