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NCT06245785 Clinical Trial

Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function

Hepatic Cancer Clinical Trial

Official title:
Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function: A Chinese Multicenter Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06245785
Other study ID # liu lei
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 1, 2023

Study information
Verified date January 2024
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hepatic dysfunction limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis. Established practice guidelines for patients with HCC and impaired liver function are lacking. The treatment allocation in these populations is heterogeneous and remains controversial. This study compared the survival benefits of liver resection (LR) and transarterial chemoembolisation (TACE) in patients with HCC and impaired liver function.

Recruitment information / eligibility
Status Completed
Enrollment 2200
Est. completion date December 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with HCC who received conventional LR or TACE Exclusion Criteria: - (1) presence of portal vein tumour thrombosis (PVTT), hepatic artery, biliary duct or inferior vena cava invasion - (2) extrahepatic spread (EHS) - (3) albumin-bilirubin grade 1 or 3 - (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) >1 - (5) tumour number >3 - (6) other tumours or severe cardiac, cerebral, and renal insufficiency - (7)ascites, hepatic encephalopathy, and jaundice

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transarterial chemoembolisation
Before TACE, hepatic arteriography was performed to evaluate the vascular anatomy and tumour vascularity. During TACE, a vascular catheter was selectively inserted into the tumour-feeding artery with an injection containing a mixture of doxorubicin (10-50 mg) and lipiodol (2-20 mL), followed by embolisation using gelatin sponge particles. TACE was repeated when residual viable tumours were confirmed or new lesions developed in patients with adequate liver function. Laboratory assessments were performed every four to six weeks. Radiological evaluation using contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) was recommended during weeks 4 and 8 after treatment and every 8 weeks thereafter. However, in clinical practice, the intensity of follow-up depends on an individual's baseline characteristics and response to the last treatment.

Locations
Country Name City State
China Tangdu hospital Xian Shaanxi
China Xijing hospital Xian Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival The overall survival rate at 5 years 5 year
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