ovarian cancer
Conditions
Interventions
treatment group:adriamycin treatment
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent; 2. Females aged 18-70 years; 3. Epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer diagnosed by histology or cytology; 4. Patients with relapsed or refractory ovarian cancer after standard treatment are collectively referred to as patients with platinum-resistant ovarian cancer; Note: Definition of standard treatment: Satisfactory cytoreductive surgery and prior platinum-based chemotherapy. Drug-resistant recurrence: the last (first-line) platinum-containing regimen, after completion of >=4 cycles of chemotherapy, the time from the end of treatment to disease progression/relapse = 3 months; 8. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; Non-surgical sterilized female patients of childbearing age must have a negative serum or urine HCG test within 72 hours before study enrollment; and must be non-lactating. The patients voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject has central nervous system metastasis confirmed by imaging; 2. There are pleural, ascites, and pericardial effusions with clinical symptoms that require intervention and drainage, or have received serous cavity effusion drainage within 1 month before the first drug; 3. Suffering from hypertension and cannot be well controlled by antihypertensive drug treatment (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 4. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; 5. Abnormal coagulation function (PT>16s, APTT>43s, Fbg= ++, the confirmed 24-hour urine protein amount is > 1.0 g; 8. Subjects who have previously received radiotherapy, chemotherapy, and surgery, and less than 4 weeks after the completion of the treatment (the last medication) and before the study medication; endocrine therapy or molecular targeted therapy has less than 5 drug half-lives from the last medication to before the study medication; subjects with adverse events (other than alopecia) due to previous treatment that did not recover to <=CTCAE grade 1; 9. Investigators who have participated in clinical trials of other drugs; 10. The subject has previously or at the same time suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ breast cancer); 11. The subjects may receive other systemic anti-tumor therapy during the study; 12. According to the judgment of the researcher, the subjects have other factors that may lead to the forced termination of the study. For example, other serious diseases (including psychiatric diseases) require concomitant treatment, and there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactYao Liangqing
Obstetrics & Gynecology Hospital, Fudan University
Outcome results
None listed