TACE Combined Surgery for the Resectable Huge HCC

NCT ID: NCT06898398

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-30

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.

Conditions

Hepatocellular Carcinoma; Hepatic Chemotherapy; Liver Cancer; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

TACE+surgery

patients underwent neoadjuvant TACE followed by surgical treatment.

TACE

Intervention Type: 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.

Surgery

Intervention Type: 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

patients underwent surgical treatment.

Surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qunfang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Duan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA general hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunfang Zhou, MD

Role: CONTACT

zhouqun988509@163.com

19868000115

Feng Duan, MD

Role: CONTACT

86 13910984586

Facility Contacts

Qunfang Zhou, MD

Role: primary

zhouqun988509@163.com

8619868000115

Feng Duan, MD

Role: backup

duanfeng@vip.sina.com

8613910984586

Other Identifiers

Liver Project 15

Identifier Type: -

Identifier Source: org_study_id