About this trial
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).
Eligibility criteria
Qualifiers
Voluntary participation with written informed consent.
Age 18-75 years.
Expected survival ≥ 12 weeks.
Histologically/cytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV).
Disqualifiers
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. -
Trial design
Treatments tested in this trial
- RC48+Carboplatin+Bevacizumab