Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer

Study Overview
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Brief Summary
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This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

Official Title
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Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Epithelial Ovarian Cancer: A Single-arm, Multi-center, Phase II Clinical Study

Conditions
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Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Recurrent Ovarian Carcinoma, Albumin-bound Paclitaxel, Bevacizumab, Survival Outcomes, Adverse Events

Intervention / Treatment
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* Combination Product: Albumin-bound paclitaxel and bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Aged 18 75 years old Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Sufficient bone marrow function; Sufficient liver and renal function; Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women; Patients had no disturbance of consciousness and volunteered to participate in the study. Exclusion Criteria Uncontrolled hypertension Tumor invading vital blood vessels With contraindications to chemotherapy With uncontrolled infection Patients had received anticancer therapy within 3 weeks before enrollment Patients were allergic or intolerant to investigational drugs or its ingredients Patients are not suitable for this trial as judged by investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with platinum-resistant recurrent epithelial ovarian cancer<br> | Combination Product: Albumin-bound paclitaxel and bevacizumab<br>* Patients will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS defined as the time the duration from date of enrollment to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first | 24 months | 
| Overall survival | Overall survival is defined as the duration from date of enrollment to the date of death from any cause | 36 months | 
| Adverse Events | Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE) | 36 months |