Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
Epithelial Ovarian Carcinoma Stage III, Epithelial Ovarian Carcinoma Stage IV, Fallopian Tube Carcinoma Stage III
About this trial
This is an interventional other trial for Epithelial Ovarian Carcinoma Stage III
Eligibility Criteria
Inclusion Criteria: Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was classified as stage III-IV according to FIGO(International Federation of Gynecology and Obstetrics)stage Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment Written informed consent Expected survival ≥6 months The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1) Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation. Exclusion Criteria: Patients with low malignant potential ovarian tumors; Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; Patients who have previously received chemotherapy or radiotherapy for pelvic cavity; Patients with central nervous system metastasis or peripheral neuropathy > grade 1; Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening; Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); According to NYHA(New York Heart Association) criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 55% indicated by color Doppler ultrasonography; Uncontrolled systemic infection requiring anti-infective treatment; Arteriovenous thrombosis events occurring within 6 months before randomization, such as cardiovascular and cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism; Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection; Pregnant or lactating women; Those who were considered unsuitable for inclusion by the researchers.
Sites / Locations
- Sun Yat-Sen University Cancer Hospital
- Qilu Hospital of Shandong University
- Yaxia ChenRecruiting
- Sir Run Run Hospital
- The First Affiliated Hospital of Medical College of Zhejiang University
- The Second Affiliated Hospital of Medical College of Zhejiang University
- Zhejiang Cancer Hospital
- Ningbo women's and children's Hospital
- The No, 1 People's Hospital of Ningbo
- The Second Affiliated Hospital of Wenzhou Medical University
- The First Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Nab-Paclitaxel/carboplatin for systemic therapy after surgery
Paclitaxel/carboplatin for systemic therapy
Nab-Paclitaxel/carboplatin q3 weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin AUC(area under the curve) 5 IV Day1 Repeat every 21 days x 6 cycles Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by carboplatin AUC(area under the curve)2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6 cycles
Paclitaxel 175 mg/m² IV followed by carboplatin AUC(area under the curve)5 IV Day·1Repeat every 21 days x 6 cycles Paclitaxel weekly/carboplatin weekly Paclitaxel 60 mg/m2 followed by carboplatin AUC(area under the curve) 2 IV Days 1.8. and 15: repeat every 21 days 6 cycles (18 weeks)