TACE Combined Surgery for the Resectable Huge HCC

March 31, 2025 updated by: Zhou Qunfang, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Feng Duan, MD
  • Phone Number: 86 13910984586

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Feng Duan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study is a multicenter, observational real-world study to compare the efficacy of TACE with surgery inhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy combined surgery. This study will create a database that will provide clinical parameters and outcomes of patients undergoing combined therapy for huge HCC therapy.

Description

Inclusion Criteria:

  1. clinical or pathological diagnosis of primary HCC;
  2. tumor diameter > 10 cm on images before inclusion;
  3. age 18 to 75 years;
  4. no macrovascular invasion or extrahepatic metastasis;
  5. liver resection with complete removal of the tumor and adequate remnant liver volume;
  6. albumin-bilirubin (ALBI) grade I and II;
  7. Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
  8. 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;
  9. prothrombin time ≤ 18 s or international normalized ratio < 1.7.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TACE+surgery
patients underwent neoadjuvant TACE followed by surgical treatment.
Procedure: TACE
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.
Procedure: Surgery
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.
Surgery
patients underwent surgical treatment.
Procedure: Surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival （RFS）
Time Frame: 24 months
RFS was defined as the time from surgery to tumor progression or the last follow-up
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 60 months
OS was defined as the time from surgery to death or the last follow-up
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Feng duan, MD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liver Project 15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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