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

Phase 2

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Fasudil Hydrochloride

• Registration Number: NCT06890858
• Lead Sponsor: Zhejiang Provincial People's Hospital

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Study Start: 2025-04
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Fasudil Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
ORR	3 years	Overall objective tumor response rate

Secondary Outcome Measures

Name	Time	Method
PFS	3 years	Progression free Survial

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China