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NCT06898398Recruiting

TACE Combined Surgery for the Resectable Huge HCC

Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis

Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. The high risk of recurrence after surgery is another challenge for surgeons. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.

Status (registry)
Recruiting
Study type
Observational
Enrollment
326 (estimated)
First submitted
21 Mar 2025
Start date
1 Jan 2025
Primary completion date
30 Dec 2025
Lead sponsor
Sun Yat-sen University
NCT number
NCT06898398

What you commit to

  • Study type: Observational
  • Planned participants: 326
  • From 1 Jan 2025 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;

Lab values

  • portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;

Other

  • HCC with macrovascular invasion or extrahepatic metastasis;
  • tumor with a maximum diameter ≤ 10 cm on images before inclusion;
  • recurrent HCC;
  • serious medical comorbidities;
  • incomplete data or lost to follow-up within three months.

Who the study is looking for

  • clinical or pathological diagnosis of primary HCC;
  • tumor diameter \> 10 cm on images before inclusion;
  • age 18 to 75 years;
  • no macrovascular invasion or extrahepatic metastasis;
  • liver resection with complete removal of the tumor and adequate remnant liver volume;
  • albumin-bilirubin (ALBI) grade I and II;
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
  • hemoglobin level ≥ 8.5 g/dL, total bilirubin level ≤ 30 mmol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal;
  • prothrombin time ≤ 18 s or international normalized ratio \< 1.7.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.