Ovarian cancer
Conditions
Interventions
Study Group:RC48 combined with VP16
Sponsors
Zhongshan Hospital Affiliated with Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form; 2. Age 18-70 years; 3. Recurrent epithelial ovarian cancer; 4. Progression after receiving at least one line of platinum-containing chemotherapy in the past, and the total number of treatment lines = 6 months; 7. ECOG physical condition 0-2 points; 8. HER2 expression: IHC 1, 2 or 3; 9. Expected survival time>=12 weeks; 10. Have measurable lesions as specified by RECIST 1.1 criteria; 11. No prior anti-HER2 therapy; 12. 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; platelets>=100 ×10^9/L; Serum total bilirubin =50 mL/min; 13. Female subjects should be surgically sterile, postmenopausal, or agree to use at least one medically approved form of contraception (such as intrauterine device, contraceptive pill, or condom) during study treatment and for 6 months after the end of the study treatment period, and must have a negative blood pregnancy test within 7 days prior to study enrollment, and must be non-lactating; 14. Willing and able to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate drugs and their components; 2. Toxicity caused by prior anti-tumor therapy has not recovered to CTCAE (version 5.0) grade 0-1 (except for second-degree alopecia); 3. Major surgery within 4 weeks prior to the start of study dosing and no complete recovery; 4. A large amount of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment; 5. Serovirological examination (subject to the normal value of the research center): positive HBsAg test result, and positive HBV DNA copy number was detected at the same time; Positive HCVAb test result (only if the PCR test result of HCV RNA is negative, the study will be enrolled); Positive HIVAb test result; 6. Received a live vaccine within 4 weeks prior to the start of study dosing or plans to receive any vaccine during the study; 7. Heart failure graded by the New York College of Cardiology (NYHA) grade 3 or above; 8. Serious arterior/venous thrombotic events or cardiovascular and cerebrovascular accidents within 1 year before study administration, such as deep vein thrombosis (excluding asymptomatic and interscalene vein thrombosis that does not require special treatment), pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., except for lacunar cerebral infarction that is asymptomatic and does not require clinical intervention; 9. Presence of active or advanced infection requiring systemic treatment, such as active tuberculosis; 10. Presence of systemic diseases that have not been stably controlled by the investigator, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.; 11. Previous allogeneic hematopoietic stem cell transplantation; 12. Has any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a certain disease or state that is not suitable for the use of the study drug, or that will affect the interpretation of the study results, or put the patient at high risk; 13. Estimated inadequate patient compliance to participate in this clinical study; 14. Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) or participated in other clinical study treatments within 4 weeks prior to the start of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Duration of Response;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactShi Tingyan
Zhongshan Hospital Affiliated with Fudan University
Outcome results
None listed