Actively Recruiting
Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment
Led by Zhejiang Cancer Hospital · Updated on 2025-12-16
20
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. However, conventional paclitaxel, due to the addition of polyoxyethylated castor oil solubilizer, may induce various adverse reactions beyond chemotherapeutic toxicity, such as hypersensitivity, toxic renal injury, neurotoxicity, and cardiovascular toxicity. Therefore, exploring optimized treatment regimens to provide patients with new therapeutic options is imperative. HER2 is a protein encoded by the ERBB2 gene that regulates cell survival, proliferation, and differentiation. HER2 gene amplification and/or protein overexpression are observed in 18%-35% of mucinous ovarian cancers. A meta-analysis involving over 5,000 ovarian cancer cases revealed that HER2 overexpression correlates with reduced overall survival (OS) and progression-free survival (PFS), suggesting its potential as a biomarker for poor prognosis. The emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48). Preliminary results from the PRaG3.0 trial presented at the 2023 ASCO Annual Meeting showed an ORR of 66.7% in six HER2-expressing gynecological cancer patients treated with RC48 combined with radiotherapy and immune checkpoint inhibitors (ICIs). Updated data from the RC48-C018 study demonstrated an ORR of 36.4%, median duration of response (mDoR) of 5.52 months, mPFS of 4.37 months, and 12-month OS rate of 66% in 22 cervical cancer patients. RC48 exhibited promising efficacy and manageable safety in recurrent/metastatic HER2-expressing (IHC 1+/2+/3+) cervical cancer. Regarding safety, the GOG-158 study reported pronounced hematologic toxicity with carboplatin-paclitaxel in advanced ovarian cancer: grade 3/4 leukopenia (\>50%), thrombocytopenia (\>30%), and neutropenia (\>80%). Conversely, a retrospective study of RC48 combined with platinum ± bevacizumab in HER2-mutated NSCLC patients showed an ORR of 71.4% with no dose reductions or discontinuations due to adverse events. Thus, RC48-platinum combinations may offer a lower-toxicity alternative. Thus the investigators designed this trial to evaluate the efficacy and safety of RC48 combined with carboplatin in HER2-expressing advanced ovarian cancer.
CONDITIONS
Official 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 pathology
- Completed first tumor debulking surgery with R0 or R1 resection
- HER2 expression with IHC 2+ or 3+
- No prior chemotherapy treatment
- ECOG performance status of 2 or less
- Expected survival of at least 3 months
- Adequate organ function including left ventricular ejection fraction ≥50%, hemoglobin ≥9 g/dL, absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L
- Serum total bilirubin ≤1.5 times upper limit of normal
- ALT and AST ≤2.5 times upper limit of normal without liver metastasis, or ≤5 times with liver metastasis
- Serum creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥50 mL/min
- Non-pregnant female
- Signed informed consent form
You will not qualify if you...
- Received other anti-tumor treatments such as radiotherapy or immunotherapy within 1 month before treatment
- Have central nervous system diseases or brain metastases
- History of grade II or higher peripheral neuropathy
- Uncontrolled serious diseases affecting treatment ability, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, hypertension, infection, or active peptic ulcer
- History of other malignant tumors within 5 years except cured skin basal cell carcinoma or cervical cancer
- Known allergies or intolerance to study drugs or their components
- Currently participating in other clinical trials
- Judged unsuitable for this study by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhe Jiang Cancer Hospital
Zhejiang, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Shao
CONTACT
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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