The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma

Translational Research of SOX4 in Hepatocellular Carcinoma Clinical Trial

— SOX4 in HCC  

Official title:

SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296058
• Other study ID #: 106-2314-B-182A-113
• Secondary ID: 103-2314-B-182A-
• Status: Completed
• Start date: January 8, 2007
• Est. completion date: March 31, 2019

Study information

• Verified date: March 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational study. The inclusion criterion was intended curative hepatectomy for HCC patients by image analysis, and the exclusion criteria were unresectable disease, synchronous cancers, recurrent cancers, or distant metastasis. The study endpoint was 30 March 2019, and tumor staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system for HCC

Description:

To determine the role of SOX4 in tumor progression in patients with HCC, we examined SOX4 expression through immunohistochemistry (IHC) staining of 200 formalin-fixed and paraffin-embedded (FFPE) HCC specimens . The SOX4 high group of patients was associated with positive etiology of hepatitis B virus (P = 0.044), tumor size >5 cm (P = 0.014), thrombus formation (P = 0.012), higher microvessel density (MVD) (P = 0.012) in tumor lesions, and distant metastasis (P <0.001).

Cox regression analysis showed that patients with elderly age (P <0.001), higher ⍺-fetal protein (AFP) (P = 0.045), presence of cirrhosis (P = 0.008), and SOX4 high in tumor specimen (P = 0.042) were independent risk factors . The SOX4 high group performed significantly worse regarding overall survival (OS) (P = 0.043) and disease-free survival (DFS) (P = 0.019) based on the Kaplan-Meier analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

subjects with pathologic diagnosis of hepatocellular carcinoma and curative partial hepatectomies -

Exclusion Criteria:

history of different malignant disease, subject cannot be treated with curative surgery -

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Translational Research of SOX4 in Hepatocellular Carcinoma

Intervention

Other:
• microvessel density
the vessel numbers in high power field with Anti-CD31 staining in tumor specimen

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	The length of time from curative hepatectomies and recurrence or mortality	a month
Secondary	Overall survival	The length of time from curative hepatectomies and still alive	a month