TACE Combined Surgery for the Resectable Huge HCC
Recruiting now
Conditions studied: Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer, Surgery
In brief
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.
Key facts
- Study ID
- NCT06898398
- Run by
- Sun Yat-sen University
- People needed
- 326
- Starts
- 2025-01-01
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2025-04-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Chinese PLA general hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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