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NCT Number: NCT06898398

TACE Combined Surgery for the Resectable Huge HCC

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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. However, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. 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 impact of neoadjuvant TACE on the long-term oncological outcomes of huge HCC requires investigation. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • HCC with macrovascular invasion or extrahepatic metastasis;
  • tumor with a maximum diameter ≤ 10 cm on images before inclusion;
  • recurrent HCC;
  • serious medical comorbidities;
  • portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
  • cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
  • incomplete data or lost to follow-up within three months.

Treatment and study plan

TACE

Procedure

TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.

Surgery

Procedure

The surgical plan was based on the tumor size, tumor location, and liver function. We applied Pringle's maneuver with cycles of clamping and unclamping times of 1-10 and 5 min, respectively, and maintained the central venous pressure below 4 mmHg during parenchymal dissection to control intraoperative bleeding.

Primary outcomes

  1. Recurrence-free survival (RFS)

    Time frame: 24 months

    RFS was defined as the time from surgery to tumor progression or the last follow-up

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 60 months

    OS was defined as the time from surgery to death or the last follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Duan, MD

CONTACT

86 13910984586

Qunfang Zhou, MD

CONTACT

[email protected]

19868000115

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Apr 3, 2025

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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