Anti-recurrence Treatment of Postresection on HCC Patients With MVI Presence and Over-expression of ASPH

Hepatocellular Carcinoma Clinical Trial

Official title:

Anti-recurrence Treatment of Postresection on Hepatocellular Carcinoma Patients With Microvascular Invasion Presence and Over-expression of Aspartate Beta-hydroxylase: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02587884
• Other study ID #: EHBHKY2015-01-024
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 26, 2015
• Last updated: March 30, 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Wang Kui, MD
• Phone: 86-021-81875242
• Email: wangkuiykl[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on the prognosis of patients with microvascular invasion presence(MVI) and overexpression of Aspartate-β-hydroxylase(ASPH).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Via clinical diagnosis and confirm it is primary liver cancer

2. Pathological evidence of HCC

3. Confirm presence of MVI and over-expression of ASPH after opreation

4. Within Milan criteria

5. Estimate tumor can gain treatment of curing operation

6. No evidence for extrahepatic metestasis

7. liver function :Child-Pugh A/B

Exclusion Criteria:

1. Reject to attend

2. Impossible to come to our hospital for physical examination regularly

3. Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction

4. Female with pregnancy or during the lactation period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Procedure:
• TACE
Patients will treated by TACE in 4 or 8 weeks after operation.

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		3 years	Yes
Secondary	Time to recurrence		3 years	Yes