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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06245785
Enrollment
2200
Registered
2024-02-07
Start date
2023-01-01
Completion date
2023-12-01
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Cancer

Brief 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.

Interventions

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.

Sponsors

Tang-Du Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
overall survival5 yearThe overall survival rate at 5 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026