Actively Recruiting
Efficacy and Safety of Disitamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in First-Line Treatment
Led by Zhejiang Cancer Hospital · Updated on 2025-12-16
20
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ovarian cancer is the deadliest among gynecological cancers. This trial explores a new treatment option for advanced ovarian cancer that expresses the HER2 protein. Researchers are studying the combination of Disitamab Vedotin (RC48), a novel antibody-drug conjugate targeting HER2, with carboplatin chemotherapy. The study aims to evaluate the treatment's safety and effectiveness in patients who have not previously received chemotherapy. Participants will receive RC48 at a dose of 2.5 mg/kg on day 1 every three weeks, combined with carboplatin dosed at AUC 5-6 on day 1 every three weeks. Treatment continues for up to six cycles. This first-line treatment regimen is designed to provide an alternative with potentially fewer side effects than traditional chemotherapy alone. During the study, participants will be monitored for progression-free survival over about one year, with additional follow-ups up to five years to assess overall survival and adverse events. Evaluations include tumor response assessments and safety monitoring throughout the treatment period. The study provides careful observation of participant health and treatment effects over the course of the trial.
CONDITIONS
Brief Title
Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage II-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by tissue examination
- Completed initial tumor cell debulking surgery with R0 or R1 resection
- HER2 protein expression at IHC 2+ or 3+
- No prior chemotherapy treatment
- ECOG performance status of 2 or less
- Expected survival of at least 3 months
- Adequate heart, blood, liver, and kidney function based on clinical tests
- Female and not pregnant
- Signed informed consent before joining the trial
You will not qualify if you...
- Received other anti-tumor treatments like radiotherapy or immunotherapy within one month before study start
- Central nervous system diseases or brain metastases
- History of moderate or severe peripheral neuropathy
- Uncontrolled serious illnesses such as severe heart disease, stroke, diabetes, hypertension, infection, or active ulcers
- History of other cancers in the past 5 years, except cured skin basal cell or cervical cancer
- Known allergies or intolerance to study drugs or their ingredients
- Participating in other clinical trials at the same time
- Considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles, 3 weeks each)
Participants receive Disitamab Vedotin and Carboplatin on day 1 of each cycle every 3 weeks, for up to 6 cycles.
6 visits (in-person, every 3 weeks)
Duration - Up to 5 years
Participants are monitored for progression-free survival, overall survival, and adverse events after treatment completion.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Zhe Jiang Cancer Hospital
Zhejiang, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Shao
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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