Actively Recruiting
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
Led by Jiangsu Cancer Institute & Hospital · Updated on 2025-12-31
43
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with written informed consent
- Age between 18 and 75 years
- Expected survival of at least 12 weeks
- Histologically or cytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV)
- HRD-negative status confirmed locally
- High-risk features such as macroscopic residual disease after primary surgery for Stage III, prior neoadjuvant chemotherapy, or Stage IV disease
- At least one measurable lesion by RECIST v1.1 criteria
- Documented HER2 expression (IHC 1+, 2+, or 3+) with available tumor tissue for confirmation
- ECOG performance status of 0 or 1
- Adequate organ function based on blood tests within 14 days before enrollment
- Urinalysis showing low protein levels
- Cardiac function within normal limits (NYHA class less than III and LVEF 50% or higher)
- Women must be surgically sterile, post-menopausal, or using approved contraception during and for 6 months after treatment
- Ability and willingness to comply with study and follow-up procedures
You will not qualify if you...
- Non-high-risk ovarian carcinoma subtypes
- Central nervous system metastases or carcinomatous meningitis
- Need for parenteral hydration/nutrition or bowel obstruction/perforation
- Peripheral neuropathy of grade 2 or higher
- Active bleeding or high risk of bleeding
- Less than 28 days between surgery and first bevacizumab dose
- Other active or recent malignancies within 5 years (except certain treated skin or cervical cancers)
- Major surgery within 4 weeks before starting study treatment and incomplete recovery
- Symptomatic large pleural effusion or ascites requiring medical intervention
- Recent live-attenuated vaccine within 30 days before treatment
- Significant blood clot or cardiovascular events within 12 months before screening
- Uncontrolled systemic diseases such as diabetes, liver cirrhosis, or severe lung disease
- Clinically relevant heart disorders including advanced AV block, uncontrolled hypertension, recent myocardial infarction, significant arrhythmia, or heart failure
- Severe infection within 4 weeks before treatment or recent major surgery
- Active autoimmune or immunodeficiency diseases requiring systemic immunosuppressive therapy
- Active or poorly controlled infections including HIV, hepatitis B or C, tuberculosis, or other severe infections
- Participation in another interventional clinical trial within 4 weeks before treatment
- Known allergies or intolerance to study drugs or their ingredients
- History of substance abuse or psychiatric disorders affecting compliance
- Any other condition that may increase risk or prevent safe study completion as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
2
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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