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RecruitingNCT06890858Updated Mar 24, 2025

A Clinical Study on Fasudil Hydrochloride for Treatment of Gene-Specific Ovarian Cancer

A Phase 2 interventional study of Fasudil Hydrochloride in Ovarian Cancer, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Zhejiang Provincial People's Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study summary

This is a prospective study investigating whether the research on Fasudil Hydrochloride in the treatment of gene-specific ovarian cancer can be applied to predict sensitivity to immunotherapy in non-small cell lung cancer (NSCLC) and other tumors. The study plans to enroll 20 patients with A/A genotype ovarian cancer for treatment evaluation.

Read the detailed description

Ovarian cancer is a common gynecological malignancy with the highest mortality rate among gynecological cancers. The poor prognosis and low survival rate in advanced-stage patients primarily contribute to its high mortality. Current clinical management of malignant ovarian tumors relies on postoperative chemotherapy and radiotherapy, which impose significant harm to the human body and offer limited improvement in patient prognosis. Additionally, the diagnostic and therapeutic cycle for malignant ovarian cancer is prolonged and unpredictable, predominantly focusing on post-surgical interventions.

In our preliminary studies, we identified that the A allele of SNP-rs1192691, associated with ovarian cancer prognosis, promotes ovarian cancer cell proliferation and invasion by activating the Rho signaling pathway. The Rho signaling pathway inhibitor Fasudil has been shown to effectively suppress the proliferation and invasion of A/A genotype tumor cells in murine models. This study aims to investigate the therapeutic efficacy of Fasudil in A/A genotype ovarian cancer patients through clinical trials, with the goal of improving their prognosis.

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Conditions studied

  • Ovarian Cancer

Keywords

  • Ovarian Cancer
  • Fasudil Hydrochloride
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 726 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients voluntarily participate in the study, sign informed consent forms, and have good compliance.
  2. After platinum based chemotherapy at Zhejiang Provincial People's Hospital, the efficacy evaluation showed that ovarian cancer patients who achieved disease stability (SD) or disease progression (PD) twice were treated with Fasudil in combination with the original chemotherapy regimen, and were confirmed to have the A/A genotype through genetic testing.

Exclusion criteria

Exclusion Criteria:

  • 1.Accompanied by hypotension 2. Bleeding like cerebral hemorrhage 3. Patients with abnormal liver function
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental: Fasudil Hydrochloride

    The specific method is as follows: (1) Administer the standard treatment plan combined with intravenous injection of Fasudil 30mg/2-3 times/day to the enrolled ovarian cancer patients, with the same duration of use as the standard treatment plan. (2) Observe the treatment effect of patients after 2-3 treatment cycles, with the main endpoint being the objective response rate (ORR) and the safety of drug use. The secondary endpoint is the PFS time after combined use of fasudil.

    Drug: Fasudil Hydrochloride

Interventions

  • DrugFasudil Hydrochloride

    Exploring whether the study of using Exploring whether the study of using Fasudil Hydrochloride for the treatment of gene specific ovarian cancer can be used to predict the sensitivity of immunotherapy for non-small cell lung cancer and other tumors for the treatment of gene specific ovarian cancer can be used to predict the sensitivity of immunotherapy for non-small cell lung cancer and other tumors

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What researchers measure

Primary outcomes

  1. ORR

    Overall objective tumor response rate

    Time frame: 3 years

Secondary outcomes

  1. PFS

    Progression free Survial

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang, China
    Recruiting
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References and documents

Publications

  • Ohta T, Takahashi T, Shibuya T, Amita M, Henmi N, Takahashi K, Kurachi H. Inhibition of the Rho/ROCK pathway enhances the efficacy of cisplatin through the blockage of hypoxia-inducible factor-1alpha in human ovarian cancer cells. Cancer Biol Ther. 2012 Jan 1;13(1):25-33. doi: 10.4161/cbt.13.1.18440. PubMed 22336585 ↗
  • Wei L, Surma M, Shi S, Lambert-Cheatham N, Shi J. Novel Insights into the Roles of Rho Kinase in Cancer. Arch Immunol Ther Exp (Warsz). 2016 Aug;64(4):259-78. doi: 10.1007/s00005-015-0382-6. Epub 2016 Jan 2. PubMed 26725045 ↗
  • McLeod R, Kumar R, Papadatos-Pastos D, Mateo J, Brown JS, Garces AHI, Ruddle R, Decordova S, Jueliger S, Ferraldeschi R, Maiques O, Sanz-Moreno V, Jones P, Traub S, Halbert G, Mellor S, Swales KE, Raynaud FI, Garrett MD, Banerji U. First-in-Human Study of AT13148, a Dual ROCK-AKT Inhibitor in Patients with Solid Tumors. Clin Cancer Res. 2020 Sep 15;26(18):4777-4784. doi: 10.1158/1078-0432.CCR-20-0700. Epub 2020 Jul 2. PubMed 32616501 ↗
  • Ogata S, Morishige K, Sawada K, Hashimoto K, Mabuchi S, Kawase C, Ooyagi C, Sakata M, Kimura T. Fasudil inhibits lysophosphatidic acid-induced invasiveness of human ovarian cancer cells. Int J Gynecol Cancer. 2009 Dec;19(9):1473-80. doi: 10.1111/IGC.0b013e3181c03909. PubMed 19955921 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06890858
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Liu Yang (MD, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Mar 24, 2025
Start date
Apr 2025 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Mar 24, 2025

Study contacts

Yang Liu, M.D.
Contact
yangliuqq2003@163.com
13666601475
Yang Liu, M.D.
study director · Zhejiang Provincial People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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