Advanced ovarian cancer and Advanced choriocarcinoma
Conditions
Interventions
Cohort A:Every four weeks in a treatment cycle, subjects will receive a combination of legubicin for injection (270 mg/m2, CnD1 and CnD15, Q2W) and bevacizumab (10 mg/kg, CnD1 and CnD15, Q2W) on the d
Cohort B1 (Study Group) :On the day of administration, subjects will receive the combination therapy of legubicin injection (270 mg/m2, CnD1 and CnD15, Q2W), bevacizumab (10 mg/kg, CnD1 and CnD15, Q2W
Cohort B2 (Control Group):On the day of administration, subjects will receive doxorubicin liposome (30 mg/m2, CnD1, Q4W), bevacizumab (15 mg/kg, CnD1, Q4W) and carboplatin (AUC 5, CnD1, Q4W) in combin
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ovarian cancer: women aged 18-75 years (including the cut-off value); Choriocarcinoma: Women or men aged 18-75 years (including the cut-off). 2. Cohort A and Cohort B: inoperable epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with stage III-IV FIGO confirmed by histology or cytopathology, and pathological types were high-grade serous, endometrioid, and carcinosarcoma. Cohort C: advanced inoperable non-gestational choriocarcinoma histologically or pathologically confirmed. 3. Cohort A: Subjects assessed by the investigators as platinum refractory/platinum resistance relapse, platinum sensitivity intolerance; Platinum refractory was defined as: no response (CR or PR) or disease progression (PD) =6 months. Cohort C: Subjects with refractory choriocarcinoma who had failed standard treatment, had no standard treatment options, or were not currently eligible for standard treatment as assessed by the investigator. 4.ECOG = 15 mm short diameter) suitable for accurate repeat measurements. 7. Organs and bone marrow function well: 8. Female subjects of reproductive age must have a negative pregnancy test at the time of screening (except for non-gestational choriocarcinoma) and use highly effective contraception during the screening period until 3 months after the last dose; Male subjects whose partner is a woman of childbearing age are required to use highly effective contraception for 3 months from the first dose to the last dose. 9. Subjects can understand the steps of this study, are willing to follow the clinical study protocol to complete this study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Subjects who are allergic to the drugs and analogues used in the study, or their excipients. 2. Patients who were platinum-refractory, defined as no response (CR or PR) or progressive disease (PD) 500 IU/ml or the lower limit of clinical research detection [only if the lower limit of clinical research is above 500 IU/ml]); Active hepatitis C (HCV antibody positive and HCV-RNA > the lower limit of detection in clinical research institutions). 9. History of immunodeficiency or positive HIV antibody test. 10. Subjects with active infection who currently require intravenous antiinfective therapy. 11. Patients with any severe and/or uncontrolled cardiovascular disease, including: (1) clinically uncontrolled hypertension (i.e., systolic blood pressure >= 160 mmHg, and/or diastolic blood pressure >= 100 mmHg). (2) severe cardiovascular and cerebrovascular diseases occurred within 6 months before the first medication, such as acute coronary syndrome, congestive heart failure (NYHA class ?-?), ischemic stroke (except lacunar infarction), and aortic dissection. (3) any factors that increase the risk of QTc prolongation or the risk of arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in an immediate family member younger than 40 years of age, or use of any concomitant medication known to prolong the QT interval (see Appendix 7 for details). 12. (Inquiry) Clinically uncontrollable third space effusion, such as pleural effusion, pericardial effusion, and peritoneal effusion, were judged by the investigators to be not suitable for inclusion in this study. 13. Occurrence of arterial/venous thrombotic events within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Patients with intermuscular venous thrombosis of the lower extremity were considered for enrollment if they were assessed as not requiring anticoagulation and if they had resolution of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging evaluation of cancer;Occurrence and frequency of dose-limiting toxicity (DLT);Solid tumors were determined by an independent review committee (IRC) Clinical Evaluation Criteria version 1.1 (RECIST) 1.1) determined objective response rate (ORR) and no progression Extended survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Diseases as determined by the IRC according to RECIST1.1 Control rate (DCR) and duration of response (DOR);Overall Survival (OS);Adverse events (AE)/serious adverse events (SAE) occurrence and frequency (according to NCI CTCAEv5.0);Vital signs;Physical examination;Eastern United States swelling Oncology cooperative group (ECOG) performance status;Experimental Laboratory examination (blood routine, blood biochemistry, urine points Analysis);12-lead electrocardiogram (ECG), ultrasound Echocardiography, markers of myocardial injury, and NT Abnormalities such as proBNP or BNP; | — |
Countries
China
Contacts
Public ContactGuiling Li
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed