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

March 18, 2025 updated by: Liu Yang, Zhejiang Provincial People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 3 years
Overall objective tumor response rate
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 3 years
Progression free Survial
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial People's Hospital

Investigators

  • Study Director: Yang Liu, M.D., Zhejiang Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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