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RECRUITING
NCT07311577
PHASE2

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

Sponsor: Jiangsu Cancer Institute & Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2026-01-01

Completion Date

2028-12-30

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

RC48+Carboplatin+Bevacizumab

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).

Locations (2)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China