Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy fo… (NCT07311577) | Clinical Trial Compass
RecruitingPhase 2
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
China43 participantsStarted 2026-01-01
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Hb ≥ 90 g/L
✓. WBC ≥ 3 × 10⁹/L
✓. ANC ≥ 1.5 × 10⁹/L
✓. PLT ≥ 90 × 10⁹/L Biochemistry
Exclusion criteria
✕. PR interval \> 0.24 s or 2nd/3rd-degree AV block.