A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

July 2, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer

To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
  2. Completion of ≥2 previous platinum-containing regimens
  3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator
  4. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion Criteria:

  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
  2. Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
  3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluzoparib capsules, 50mg per capsule
Fluzoparib capsules, PO
Drug: Fluzoparib capsules
Fluzoparib capsules
Other Names:
  • SHR-3162
Placebo Comparator: Placebo capsules, 50mg per capsule
Placebo capsules, PO
Drug: Placebo capsules
Placebo capsule
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
Time Frame: up to 2 years
Defined as progression free survival per RECIST 1.1 criteria
up to 2 years
Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant
Time Frame: up to 2 years
Defined as progression free survival per RECIST 1.1 criteria
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS) in relapsed ovarian cancer patients
Time Frame: up to 2 years
PFS is Progression-Free-Survival per RECIST 1.1 criteria
up to 2 years
Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria
Time Frame: up to 2 years
TTP is Time to Progression
up to 2 years
Chemotherapy free interval (CFI) CFI
Time Frame: up to 2 years
CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)
up to 2 years
overall survival(OS)
Time Frame: up to 3 years
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
up to 3 years
Objective Response Rate
Time Frame: At baseline,at the time point of every 12 weeks, up to 2 years
Objective Response Rate complete or partial response per RECIST 1.1 criteria
At baseline,at the time point of every 12 weeks, up to 2 years
Adverse Events(AEs) and Serious Adverse Events (SAEs)
Time Frame: from the first drug administration to within 30 days for the last treatment dose
assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.
from the first drug administration to within 30 days for the last treatment dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: lingying wu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

June 19, 2025

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

March 3, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZPL-Ⅲ-301-OC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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