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NCT04507841
Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
Phase 2 trial testing Niraparib in Ovarian Cancer in 67 participants. Participants enrolled and being followed up; not accepting new ones.
25 September 2023
Quick facts
| Lead sponsor | Tongji Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 8 January 2021 |
| Primary completion | 25 September 2023 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Niraparib (niraparib) — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
Tongji Hospital
Who can join
Adults 18 to 75, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who had low likelihood of achieving R0 cytoreduction by imaging assessment or laparoscopic evaluation, or cannot tolerate PDS by poor conditions.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoadjuvant PARPi or chemotherapy in ovarian cancer informs targeting effector Treg cells for homologous-recombination-deficient tumors.
Luo Y, Xia Y, Liu D, Li X, et al · · 2024 · cited 68× · PMID 38971151 · DOI 10.1016/j.cell.2024.06.013 -
Synthetic Lethality in Ovarian Cancer.
Chandrasekaran A, Elias KM. · · 2021 · cited 34× · PMID 34518297 · DOI 10.1158/1535-7163.mct-21-0500 -
PARP inhibitors enhance antitumor immune responses by triggering pyroptosis via TNF-caspase 8-GSDMD/E axis in ovarian cancer.
Xia Y, Huang P, Qian YY, Wang Z, et al · · 2024 · cited 27× · PMID 39366751 · DOI 10.1136/jitc-2024-009032 -
The potential of PARP inhibitors in targeted cancer therapy and immunotherapy.
Hunia J, Gawalski K, Szredzka A, Suskiewicz MJ, et al · · 2022 · cited 25× · PMID 36533080 · DOI 10.3389/fmolb.2022.1073797 -
Neoadjuvant treatment in ovarian cancer: New perspectives, new challenges.
Nikolaidi A, Fountzilas E, Fostira F, Psyrri A, et al · · 2022 · cited 21× · PMID 35957909 · DOI 10.3389/fonc.2022.820128 -
Effectiveness and Safety of Niraparib as Neoadjuvant Therapy in Advanced Ovarian Cancer With Homologous Recombination Deficiency (NANT): Study Protocol for a Prospective, Multicenter, Exploratory, Phase 2, Single-Arm Study.
Zhou D, Liu J, Liu R, Li H, et al · · 2022 · cited 12× · PMID 35402241 · DOI 10.3389/fonc.2022.852772 -
Niraparib restricts intraperitoneal metastases of ovarian cancer by eliciting CD36-dependent ferroptosis.
Jin N, Qian YY, Jiao XF, Wang Z, et al · · 2025 · cited 10× · PMID 39922130 · DOI 10.1016/j.redox.2025.103528 -
PARP Inhibitors in the Neoadjuvant Setting; A Comprehensive Overview of the Rationale for their Use, Past and Ongoing Clinical Trials.
Habaka M, Daly GR, Shinyanbola D, Alabdulrahman M, et al · · 2025 · cited 9× · PMID 40192976 · DOI 10.1007/s11912-025-01669-z
Verify or expand the search:
- PubMed search for NCT04507841
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06682780 — A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
- NCT06887933 — A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ov · Phase 4 · not yet recruiting
- NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- 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 Tongji Hospital trials
Trials by the same sponsor.
- NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
- NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
- NCT07537959 — Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases · NA · not yet recruiting
- NCT07527260 — Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR · NA · not yet recruiting
- NCT07524712 — Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough · NA · not yet recruiting
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 NCT04507841 (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 Tongji Hospital
- Last refreshed: 17 December 2024
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/NCT04507841.
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