TACE Combined Surgery for the Resectable Huge HCC

Recruiting

• Conditions: Hepatocellular Carcinoma; Liver Cancer; Hepatic Chemotherapy; Surgery

• Registration Number: NCT06898398
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Study First Posted: 2025-03-27
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 326

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival （RFS）	24 months	RFS was defined as the time from surgery to tumor progression or the last follow-up

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	60 months	OS was defined as the time from surgery to death or the last follow-up

Trial Locations

Locations (1)

Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China