Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD-Negative High-Risk Ovarian Cancer: A Multicenter, Non-Randomized, Single-Arm Phase II Clinical Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Cancer Institute & Hospital

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

Treatment groups

43 Participants
are divided into 1 treatment group