Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer

Sponsor
Qilu Hospital of Shandong University
Study ID
NCT06735326
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Fluzoparib — DRUG
    Fluzoparib capsule (50mg per capsule) 150mg po BID
  • Bevacizumab — DRUG
    Bevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W
  • Paclitaxel — DRUG
    Paclitaxel injection 135-175mg/㎡ ivdrip Q3W
  • Carboplatin — DRUG
    Carboplatin injection AUC=4-5 ivdrip Q3W

Study Details

This study is a randomized, open-label, multi-cohort, multicenter clinical trial, aimed at evaluating the efficacy and safety of Fluzoparib monotherapy, Fluzoparib in combination with Bevacizumab, and standard chemotherapy (Paclitaxel plus Carboplatin) as neoadjuvant treatments in newly diagnosed, germline BRCA1/2-mutated epithelial ovarian cancer patients (FIGO stage III/IV). The study also aims to assess the efficacy and safety of Fluzoparib as maintenance therapy following surgery and chemotherapy. The primary endpoint of the study is the objective response rate (ORR) for neoadjuvant therapy, as assessed by the investigator using RECIST v1.1 criteria. Secondary endpoints include R0 resection rate, overall survival (OS), and progression-free survival (PFS). The study will also evaluate the safety, tolerability, and patient-reported outcomes (EQ-5D-5L) across the three treatment cohorts.

Key Dates

First listed
Dec 16, 2024
Start date
Nov 27, 2024
Status verified
Dec 2024
Primary completion
Aug 1, 2026
Completion
Oct 1, 2028

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzoparib monotherapy
    Fluzoparib capsules with a treatment cycle of 28 days, for a total of 2 cycles.
  • Experimental: Fluzoparib in combination with Bevacizumab
    Fluzoparib capsules with a treatment cycle of 28 days, for a total of 2 cycles; in combination with Bevacizumab injection (7.5mg/kg, intravenous infusion, administered once every three weeks), for a total of 2 doses.
  • Active Comparator: Paclitaxel plus Carboplatin
    Paclitaxel injection plus Carboplatin injection, administered once every three weeks for a total of 3 doses. If there is an allergy to Paclitaxel, it is recommended to replace it with Docetaxel or Liposomal Doxorubicin.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: At the end of neoadjuvant treatment. The Fluzoparib monotherapy and Fluzoparib plus Bevacizumab groups will receive 2 cycles of treatment (28 days per cycle). The Paclitaxel plus Carboplatin group will receive 3 cycles of treatment (21 days per cycle). ]

Central Contacts

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