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NCT03863860
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
Phase 3 trial testing Fluzoparib capsules in Ovarian Cancer in 252 participants. Completed in 19 June 2025.
10 January 2022
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 252 |
| Start date | 30 April 2019 |
| Primary completion | 10 January 2022 |
| Estimated completion | 19 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fluzoparib capsules — full drug profile →
- Placebo capsules — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181 -
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6 -
Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103 -
Fuzuloparib: First Approval.
Lee A. · · 2021 · cited 63× · PMID 34118019 · DOI 10.1007/s40265-021-01541-x -
Maintenance therapy for newly diagnosed epithelial ovarian cancer- a review.
Nag S, Aggarwal S, Rauthan A, Warrier N. · · 2022 · cited 28× · PMID 35902911 · DOI 10.1186/s13048-022-01020-1 -
Targeting Oncogenic Pathways in the Era of Personalized Oncology: A Systemic Analysis Reveals Highly Mutated Signaling Pathways in Cancer Patients and Potential Therapeutic Targets.
Karagiannakos A, Adamaki M, Tsintarakis A, Vojtesek B, et al · · 2022 · cited 24× · PMID 35158934 · DOI 10.3390/cancers14030664 -
Phase I dose-escalation and expansion study of PARP inhibitor, fluzoparib (SHR3162), in patients with advanced solid tumors.
Li H, Liu R, Shao B, Ran R, et al · · 2020 · cited 22× · PMID 32694901 · DOI 10.21147/j.issn.1000-9604.2020.03.08 -
Mapping genetic interactions in cancer: a road to rational combination therapies.
Tutuncuoglu B, Krogan NJ. · · 2019 · cited 17× · PMID 31640753 · DOI 10.1186/s13073-019-0680-4
Verify or expand the search:
- PubMed search for NCT03863860
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
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- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03863860 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 3 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03863860.
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