Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer
- Sponsor
- Shandong University
- Study ID
- NCT04670978
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Objective Response Rate
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- albumin-bound paclitaxe combined with bevacizumab biosimilar — DRUGalbumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity
Study Details
The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
Key Dates
- First listed
- Dec 17, 2020
- Start date
- Mar 31, 2021
- Status verified
- Apr 2023
- Primary completion
- Dec 31, 2023
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 96 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: albumin-bound paclitaxe combined with bevacizumab biosimilaralbumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks
Primary Outcome Measure
objective response rate [ Time Frame: Assessed at the end of 6 cycle(each cycle is 21 days) ]
Central Contacts
- Beihua Kong18560081888