RecruitingNCT06898398

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


Sponsor

Sun Yat-sen University

Enrollment

326 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Chinese PLA general hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06898398


Related Trials