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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06898398
Enrollment
326
Registered
2025-03-27
Start date
2025-01-01
Completion date
2025-12-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Chemotherapy, Hepatocellular Carcinoma, Liver Cancer, Surgery

Keywords

huge hepatocellular carcinoma, TACE, Surgery

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.

Interventions

PROCEDURETACE

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.

PROCEDURESurgery

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.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-free survival (RFS)24 monthsRFS was defined as the time from surgery to tumor progression or the last follow-up

Secondary

MeasureTime frameDescription
Overall survival (OS)60 monthsOS was defined as the time from surgery to death or the last follow-up

Countries

China

Contacts

Primary ContactQunfang Zhou, MD
zhouqun988509@163.com19868000115
Backup ContactFeng Duan, MD
86 13910984586

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026