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

NCT06890858 | Recruiting Phase 2 DMC

• 1 other identifier: KY2024213
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Fasudil Hydrochloride

Outcome Measures

Primary Outcomes (1)

• ORR

  Overall objective tumor response rate

  3 years

Secondary Outcomes (1)

• PFS

  3 years

Study Arms (1)

Experimental: Fasudil Hydrochloride

EXPERIMENTAL

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

Fasudil Hydrochloride DRUG

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

Experimental: Fasudil Hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participate in the study, sign informed consent forms, and have good compliance.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 22336585 BACKGROUND

• 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.

  PMID: 26725045 BACKGROUND

• 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.

  PMID: 32616501 BACKGROUND

• 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.

  PMID: 19955921 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fasudil

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Yang Liu, M.D.

  Zhejiang Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yang Liu, M.D.

CONTACT

13666601475; yangliuqq2003@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)