Platinum sensitive recurrent ovarian cancer
Conditions
Interventions
Intervention group:Paclitaxel polymer micelles+Carboplatin+Bevacizumab
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 2.Female, aged between 18 and 75 years old (calculated on the day of signing informed consent); 3.Patients with platinum sensitive recurrent high-grade (serous or endometrioid) epithelial ovarian cancer (including primary peritoneal and/or fallopian tube cancer) diagnosed histologically; Platinum sensitive diseases refer to disease progression occurring at least 6 months after completing the last dose of platinum chemotherapy; 4.At least one measurable lesion that meets the RECIST v1.1 criteria; 5.ECOG score: 0 to 1; 6.Expected survival time >= 3 months; 7.The function of important organs meets the following requirements (no blood components or cell growth factors are allowed to be used within the first 14 days of randomization): absolute neutrophil count >= 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; Hemoglobin >= 9 g/dL; Bilirubin <= 1.5 times ULN; ALT and AST <= 3 times ULN; Serum creatinine <= 1.5 times ULN; 8.For female subjects of childbearing age, a urine or serum pregnancy test should be conducted within 3 days prior to the first dose of neoadjuvant therapy (Day 1 of the first cycle) and the result should be negative. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects must use contraceptive measures with an annual failure rate of less than 1% during the treatment period.
Exclusion criteria
Exclusion criteria: 1.Confirmed allergy to the experimental drug and/or its excipients; 2.Pregnant or lactating women; 3.Arterial/venous thrombotic events that occurred within 6 months prior to the first study medication, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism; Within 2 weeks prior to the first medication, there is an active infection with CTCAE >= 2 that requires treatment with systemic antibiotics; 4.Combining severe cardiovascular diseases, including hypertension (BP >= 160/95mmHg) that cannot be controlled by internal medicine treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA class II, severe arrhythmia, and pericardial effusion; 5.Has undergone major surgery within 4 weeks prior to enrollment, or the surgical wound has not fully healed; 6.The toxic reactions caused by previous anti-tumor treatments are still >= CTC AE level 2; 7.When clinical symptoms and signs suspect brain metastasis, head MRI examination should be performed. If brain metastasis is found, it cannot be included in the study; 8.Having malignant tumors of other histological origins within the past 5 years, except for fully treated cervical carcinoma in situ and basal cell carcinoma or squamous cell carcinoma of the skin; 9.Patients with tuberculosis, HIV infection, or HBV and HCV with abnormal liver function; 10.According to the researchers' judgment, patients who are not suitable to receive bevacizumab 15 mg/kg at the beginning of treatment; 11.According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as non-compliance with the protocol, the need for concomitant treatment for other serious illnesses (including mental illnesses), serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS);Adverse Event(AE);Disease Control Rate(DCT);Serious Adverse Event(SAE);Overall survival; | — |
Countries
China
Contacts
Public ContactTao Zhu, Shao Zhuyan
Zhejiang Cancer Hospital
Outcome results
None listed