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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall objective tumor response rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free Survial | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, M.D. | Contact | 13666601475 | yangliuqq2003@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Liu, M.D. | Zhejiang Provincial People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22336585 | Background | 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. | |
| 26725045 | Background |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C049347 | fasudil |
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|
| 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. |
| 32616501 | 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. |
| 19955921 | 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. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |