Clinical trial NCT06898398: TACE Combined Surgery for the Resectable Huge HCC
Official title: Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Hepatic Chemotherapy
Liver Cancer
Surgery
Keywords: huge hepatocellular carcinoma
TACE
Surgery
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a multicenter, observational real-world study to compare the efficacy of TACE with surgery inhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy combined surgery. This study will create a database that will provide clinical parameters and outcomes of patients undergoing combined therapy for huge HCC therapy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free survival （RFS）
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Feng Duan, MD
role: PRINCIPAL_INVESTIGATOR
References: