First-line Olaparib Combined With Bevacizumab Maintenance Therapy

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05440578
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib plus bevacizumab maintenance therapy — DRUG
    First-line olaparib plus bevacizumab maintenance therapy initiated from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required).

Study Details

Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.

Key Dates

Start date
Jun 30, 2022
Status verified
Jun 2022
Primary completion
Sep 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: olaparib plus bevacizumab treatment group
    olaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.

Primary Outcome Measure

1-yr PFS rate [ Time Frame: 12 months after date of first dose ]

Related Studies