Ovarian cancer
Conditions
Interventions
Experimental group:Etoposide Capsules combined with Bevacizumab and Epalrestatolovirilumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75, female; 2.According to RECIST 1.1 criteria, there are measurable lesions at baseline; 3.ECOG PS: 0-1; 4.Platinum-resistant or platinum-refractory recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; 10 white slides are provided for pathological type confirmation and exploration of efficacy markers, and all of the following conditions must be met. (1)Received >=1 and =4 weeks and = 90g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet (PLT) >= 90×10^9/L;Biochemical test: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60mL/min;Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =2+, 24-hour urine protein quantification should be = 50%. 6.Non-surgically sterilized or women of childbearing age must use two medically approved contraceptive methods (such as intrauterine devices, contraceptives, or condoms) during the study treatment period and within 3 months after the end of the study treatment. For non-surgically sterilized women of childbearing age, the serum HCG test must be negative within 72 hours before the first dose, and they must not be lactating. For male patients whose partners are of childbearing age, two effective contraceptive methods must be used during the study treatment period and within 3 months after the end of the study treatment. 7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients who are participating in other clinical trials simultaneously; 2.Individuals with allergic constitution, including a history of severe drug allergy or drug allergic reaction; known allergy or intolerance to the study drug; 3.Patients without measurable lesions or whose lesions are unassessable; 4.Subjects with untreated central nervous system metastasis, who have previously received systemic, radical brain or meningeal metastasis treatment (radiotherapy or surgery), as long as the condition is confirmed stable by imaging and has been maintained for at least 1 month, and have stopped systemic hormone therapy (dose > 10mg/day prednisone or other equivalent efficacy hormones) for more than 2 weeks, without clinical symptoms, can be included; 5.Patients who have difficulty swallowing pills or have abnormal gastrointestinal function, as determined by the investigator, which may affect drug absorption; 6.Patients who have experienced intestinal obstruction in the recent 3 months; 7.Patients currently have uncontrollable malignant pleural effusion, ascites or pericardial effusion (defined as those that cannot be effectively controlled by diuretics or puncture methods as determined by the investigator); 8.Patients with uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known HIV infection or AIDS history; active syphilis; active tuberculosis; active infection; uncontrolled hypertension, symptomatic heart failure; active bleeding; 9.Within 5 years before the initial administration of the study drug, has a history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or other malignant tumors (except for complete remission of in situ carcinoma and malignant tumors determined by the investigator to have a slow progression); 10.Has previously (within 5 years) or concurrently has other untreated malignant tumors, except for cured skin basal cell carcinoma, cervical in situ carcinoma and breast cancer that has completed radical surgery and has no recurrence for more than 3 years; 11.Pregnant or lactating women; 12.As determined by the investigator, the subject has other factors that may lead to the study being prematurely terminated, such as other severe diseases (including mental disorders) that require combined treatment, severe laboratory abnormalities, factors related to family or society that may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactXingzhu Ju
Fudan University Shanghai Cancer Center
Outcome results
None listed