Overview
The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with solvent-based taxanes as first-line treatment for patients with advanced primary epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube carcinoma.
Description
One of the major challenges related to solvent-based taxanes administration in clinical practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed its considerable survival and low toxicity profiles in first-line treatment for several solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer (EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current clinical studies of primary EOC treatment and aim to explore the potential feasibility of nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or fallopian tube carcinoma.
Eligibility
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.