Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ov… (NCT04670978) | Clinical Trial Compass
UnknownPhase 2
Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer
China96 participantsStarted 2021-03-31
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy
✓. Patients had received at least one prior line of platinum-based chemotherapy
✓. Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1
✓. life expectancy ≥3 months
✓. ≥30 days after surgery, the body has recovered and there is no active infection
✓. Patients had received at least 1 prior line of platinum-based chemotherapy and were recurrent or progressed within 6 months after the end of the last platinum-based regimen
✓. Must have adequate hematologic and hepatic function
Exclusion criteria
✕. Previously received bevacizumab.
✕. History of other invasive malignancy with the exception of nonmelanoma skin cancer
✕. Participate in other drug trials
✕. Blood pressure of \>150/100 mmHg on antihypertensive medications
✕
What they're measuring
1
objective response rate
Timeframe: Assessed at the end of 6 cycle(each cycle is 21 days)