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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05310344
Other study ID # ALBPAC1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 27, 2022
Est. completion date March 27, 2024

Study information

Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 27, 2024
Est. primary completion date March 27, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria 1. Aged 18~75 years old 2. Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer 3. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Sufficient bone marrow function; 6. Sufficient liver and renal function; 7. 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; 8. Patients had no disturbance of consciousness and volunteered to participate in the study. Exclusion Criteria 1. Uncontrolled hypertension 2. Tumor invading vital blood vessels 3. With contraindications to chemotherapy 4. With uncontrolled infection 5. Patients had received anticancer therapy within 3 weeks before enrollment 6. Patients were allergic or intolerant to investigational drugs or its ingredients 7. Patients are not suitable for this trial as judged by investigators

Study Design


Intervention

Combination Product:
Albumin-bound paclitaxel and bevacizumab
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.

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Overall survival Overall survival is defined as the duration from date of enrollment to the date of death from any cause 36 months
Secondary Adverse Events Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE) 36 months
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