Advanced ovarian cancer
Conditions
Interventions
Test group:RC48 (Disitamab Vedotin) combined with carboplatin adjuvant therapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histopathological confirmed stage II-IV epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer; 2. Primary cytoreductive surgery with residual tumor size of 0-1cm before enrollment; 3. High expression of HER2: IHC 2+ or 3+; 4. No previous chemotherapy; 5. ECOG PS= 3 months; 7. Adequate organ function, the following criteria should be met during the screening period (normal values are subject to the clinical trial center): Left ventricular ejection fraction >=50%; hemoglobin >=9 g/dL; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet >= 100 ×10^9/L; Serum total bilirubin =50 mL/min; 8. Non-lactating females; 9.Signed written informed consent prior to the trial.
Exclusion criteria
Exclusion criteria: 1. Having received other anti-tumor therapy (such as radiotherapy and immunotherapy) within 1 month before starting treatment; 2. With central nervous system disease or brain metastases; 3. Previous peripheral neuropathy of the second degree or above; 4. Uncontrolled serious diseases that will affect the ability to receive treatment under the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 5. History of other malignant tumors within 5 years (except for cured basal carcinoma of the skin and carcinoma in situ of the cervix); 6. With known allergy or intolerance to study-related drugs or their excipients; 7. Participating in other clinical trials at the same time; 8.Unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(Progression Free Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactShao Zhuyan
Zhejiang Cancer Hospital
Outcome results
None listed