TACE Combined Surgery for the Resectable Huge HCC

NCT06898398 | Recruiting

• 1 other identifier: Liver Project 15
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Hepatic Chemotherapy; Liver Cancer; Surgery

Keywords

huge hepatocellular carcinoma; TACE; Surgery

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival （RFS）

  RFS was defined as the time from surgery to tumor progression or the last follow-up

  24 months

Secondary Outcomes (1)

• Overall survival (OS)

  60 months

Study Arms (2)

TACE+surgery

patients underwent neoadjuvant TACE followed by surgical treatment.

Procedure: TACE; Procedure: Surgery

Surgery

patients underwent surgical treatment.

Procedure: Surgery

Interventions

TACE PROCEDURE

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.

TACE+surgery

Surgery PROCEDURE

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.

Surgery; TACE+surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• clinical or pathological diagnosis of primary HCC;
• 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;
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CN (1)