TACE Combined Surgery for the Resectable Huge HCC
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TACE, Surgery.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer, Surgery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis
Overview
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
- 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.
Primary outcome measures
- Recurrence-free survival （RFS） [Time frame: 24 months]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: 60 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chinese PLA general hospital — Beijing
Identifiers
NCT: NCT06898398 · Liver Project 15