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Completed

NCT Number: NCT06245785

Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tangdu hospital, Xi'an, Shaanxi, China

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transarterial chemoembolisation

Procedure

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.

Primary outcomes

  1. overall survival

    Time frame: 5 year

    The overall survival rate at 5 years

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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