Ovarian cancer
Conditions
Interventions
Experimental group:Trastuzumab 5.4mg/kg iv q3w + pembrolizumab 2mg/kg iv q3w
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily participate in this trial and sign the informed consent form; 2. Be between the ages of 18 and 70; 3. Female patients diagnosed with epithelial ovarian cancer by surgical pathology; 4. Patients with recurrence of platinum resistance clinically diagnosed; 5. Disease progression or inability to tolerate first-line treatment after receiving first-line therapy; 6. Pathological immunohistochemistry confirmed that the expression of HER2 in tumor tissue was at least 1; 7. Imaging evaluation according to RECIST version 1.1, lesions can be measured or evaluated according to GCIG criteria for patients CA125; 8. Performance status score ECOG=50%; 10. Bone marrow function: neutrophil >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin>=90g/L; 11. Liver and kidney function: serum creatinine <=1.5x upper limit of normal (ULN), bilirubin <=1.5x ULN, AST or ALT<=2.5x ULN, no liver metastases; 12. Those who are willing and promise to cooperate in accordance with the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the active ingredients or excipients of trastuzumab or pembrolizumab; 2. Patients with non-infectious interstitial lung disease or pneumonia; 3. Patients with active systemic autoimmune diseases; 4. Patients with severe liver and kidney insufficiency; 5. Those with abnormal thyroid function and need medication; 6. Those with active infection or other malignant tumors that require treatment; 7. Patients with lung inflammation requiring systemic corticosteroid treatment; 8. Those with immunodeficiency or receiving immunosuppressive therapy; 9. Current clinical symptoms of cerebral dysfunction or severe psychiatric illness that cannot understand or follow the study protocol; 10. Patients with previous or current cardiac disease classified as Grade 2 or above by the New York Heart Association; 11. Any condition that, in the opinion of the investigator, may increase the risk of the subject or interfere with the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactYuan Zhang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed