ovarian cancer
Conditions
Interventions
experimental group:Distamab Vedotin combined with carboplatin and bevacizumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed ovarian epithelial carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma; 2. Platinum-sensitive relapsing patients who have received at least one line of standard therapy (=6 months between the time of recurrence or progression and the time of the last platinum-containing chemotherapy (at least 4 cycles)); 3. Voluntarily agree to participate in the study and sign the informed consent; 4. Female, =18 years old; 5. Expected survival =12 weeks; 6. HER2 expression: IHC 1+, 2+, 3+; 7. Have measurable lesions specified in RECIST 1.1; 8. ECOG physical condition 0 or 1 score; 9. Adequate organ function should meet the following criteria during the screening period (normal values are based on the clinical trial center) : left ventricular ejection fraction =50%; Hemoglobin =9g/dL; Absolute neutrophil count (ANC)=1.5×109/L; Platelet =100 ×109/L; Serum total bilirubin =1.5 times the upper limit of normal (ULN); ALT and AST=2.5 × ULN without liver metastasis, ALT and AST=5 × ULN with liver metastasis; Blood creatinine =1.5×ULN or creatinine clearance (CrCl)=50 mL/min according to Cockcroft-Gault formula method; 10. Female subjects should be surgically sterilized, postmenopausal, or consenting to use at least one medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period, a blood pregnancy test must be negative within 7 days prior to study enrollment, and must be non-lactating. 11. Willing and able to follow trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Have central nervous system metastatic and/or cancerous meningitis. Participants who have previously received BMS may be considered for participation in this study if their disease has been stable for at least 3 months, imaging has determined that no disease progression has occurred during the 4 weeks prior to the first dosing of the study, all neurological symptoms have returned to baseline, and there is no evidence of new or expanded BMS. The use of radiation, surgery, or steroid therapy was discontinued at least 28 days before the first administration of the study treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether it is clinically stable; 2. Toxicity caused by previous anti-tumor therapy has not returned to CTCAE(version 5.0) level 0-1 (except for 2 degree alopecia); 3. Major surgery was performed within 4 weeks before the start of study administration and did not fully recover; 4. A large amount of pleural fluid or ascites accompanied by clinical symptoms or symptomatic treatment; 5. Serum virology examination (based on the normal value of the research center) : HBsAg test results were positive, while HBV DNA copy number was positive; HCVAb test results were positive (HCV RNA PCR test results were negative only to be included in this study); The HIVAb test came back positive. 6. Had received a live vaccine within 4 weeks prior to the start of the study administration or planned to receive any vaccine during the study period (other than COVID-19 vaccination); 7. Heart failure rated grade 3 or higher by the New York College of Cardiology (NYHA); 8. Severe arteriovenous thrombosis events or cardiovascular and cerebrovascular accidents occurred within 1 year before administration of the study, such as deep vein thrombosis (excluding asymptomatic intermuscular venous thrombosis without special treatment), pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., excluding asymptomatic lacunar infarction without clinical intervention; 9. There is an active or progressive infection that requires systematic treatment, such as active tuberculosis; 10. There are systemic diseases that have not been stably controlled by researchers, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.; 11. Study the presence of active autoimmune diseases requiring systemic treatment (such as immunomodulatory drugs, corticosteroids, or immunosuppressants) within 2 years prior to initiation of administration, allowing for relevant replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency); 12. Other malignancies within 5 years prior to the start of study dosing, except malignancies that are expected to recover after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery); 13. Previously received allogeneic hematopoietic stem cell transplantation; 14. Previous treatment with other antibody-coupled drugs; 15. Those who are known to be allergic to recombinant humanized anti-HER2 monoclonal antibody -MMAE coupling agent and its components; 16. Has any other disease, metabolic abnormality, abnormal physical examination or abnormal laboratory examination, which, in the investigator's judgment, reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Control Rate;During of response;Adverse events; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Outcome results
None listed