Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Cancer
• Intervention / Treatment: Procedure: transarterial chemoembolisation

• Study Type: Observational
• Enrollment (Actual): 2200

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710000
      • Tangdu Hospital
    • Xian, Shaanxi, China, 710000
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Study data were extracted from a nationwide database of patients with HCC treated at 15 Chinese centres between January 2012 and December 2022.We included patients who were diagnosed with HCC according to the American Association for the Study of the Liver Disease/European Association for the Study of the Liver Guidelines and who received conventional LR or TACE

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
liver resection
transarterial chemoembolisation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	The overall survival rate at 5 years	5 year

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Principal Investigator: zhao s jie, Teachers and students

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: liu lei

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No