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

Phase 2

• Conditions: Adverse Events; Ovarian Carcinoma; Platinum-resistant Ovarian Cancer; Albumin-bound Paclitaxel; Bevacizumab; Recurrent Ovarian Carcinoma; Survival Outcomes
• Interventions: Combination Product: Albumin-bound paclitaxel and bevacizumab

• Registration Number: NCT05310344
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-03-26
• Last Update Submitted: 2022-03-26
• Study Start: 2022-03-27
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2023-03-27
• Study Completion: 2024-03-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with platinum-resistant recurrent epithelial ovarian cancer	Albumin-bound paclitaxel and bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	24 months	ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Adverse Events	36 months	Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Progression-Free Survival (PFS)	24 months	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
Overall survival	36 months	Overall survival is defined as the duration from date of enrollment to the date of death from any cause

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China