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Ovarian CancerPhase 3NCT03863860

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

A Phase 3 study testing Fluzoparib capsules in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Fluzoparib capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
1 siteChina
Study dates
30 Apr 2019to 19 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
  • 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).
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: 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

Conditions
Ovarian Cancer
Being tested
Fluzoparib capsules, Placebo capsules
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluzoparib capsulesDrug

    Also called SHR-3162

    Fluzoparib capsules

  • Placebo capsulesDrug

    Also called Placebo

    Placebo capsule

Study groups in NCT03863860
Study groupRoleWhat they receive
Fluzoparib capsules, 50mg per capsuleExperimentalFluzoparib capsules, PO
Receives: Drug: Fluzoparib capsules
Placebo capsules, 50mg per capsulePlacebo comparatorPlacebo capsules, PO
Receives: Drug: Placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients

    Defined as progression free survival per RECIST 1.1 criteria

    Measured: up to 2 years

  2. Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant

    Defined as progression free survival per RECIST 1.1 criteria

    Measured: up to 2 years

Secondary outcomes (6)

  1. Progression free survival(PFS) in relapsed ovarian cancer patients

    PFS is Progression-Free-Survival per RECIST 1.1 criteria

    Measured: up to 2 years

  2. Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria

    TTP is Time to Progression

    Measured: up to 2 years

  3. Chemotherapy free interval (CFI) CFI

    CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)

    Measured: up to 2 years

  4. overall survival(OS)

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

    Measured: up to 3 years

  5. Objective Response Rate

    Objective Response Rate complete or partial response per RECIST 1.1 criteria

    Measured: At baseline,at the time point of every 12 weeks, up to 2 years

  6. Adverse Events(AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: from the first drug administration to within 30 days for the last treatment dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start30 Apr 2019
  3. Primary completion10 Jan 2022
  4. Study completion19 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03863860
Sponsor's protocol ID
FZPL-Ⅲ-301-OC
Status last verified
Jul 2025
First submitted
25 Feb 2019
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li N, Zhang Y, Wang J, Zhu J, Wang L, Wu X, Yao D, Wu Q, Liu J, Tang J, Yin R, Lou G, An R, Zhang G, Xia X, Li Q, Zhu Y, Zheng H, Yang X, Hu Y, Zhang X, Hao M, Huang Y, Lin Z, Wang D, Guo X, Yao S, Wan X, Zhou H, Yao L, Yang X, Cui H, Meng Y, Zhang S, Qu J, Zhang B, Zou J, Wu L. Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial. J Clin Oncol. 2022 Aug 1;40(22):2436-2446. doi: 10.1200/JCO.21.01511. Epub 2022 Apr 11.

    PubMed 35404684

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluzoparib capsules in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863860, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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