TACE+RFA Versus Re-resection for Recurrent Small Hepatocellular Carcinoma

NCT01833286 | Unknown Phase 3 DMC

• 2 other identifiers: TACE+RFA VS. Re-resection5010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. Our previous retrospective study demonstrated that RFA was comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE is superior to re-resection for recurrent small HCC. The aim of this retrospective study is to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial hepatectomy.

Conditions

Hepatocellular Carcinoma; Surgery; Ablation

Keywords

hepatocellular carcinoma; repeat hepatectomy; radiofrequency ablation; transcatheter arterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• overall survival

  5 year

Secondary Outcomes (1)

• disease-free survival

  5 year

Other Outcomes (2)

• Mortality

  30 days

• Morbidity

  30 days

Study Arms (2)

TACE+RFA

EXPERIMENTAL

TACE was performed according to the following protocol: All patients underwent a distal super-selective catheterization of the hepatic arteries using a coaxial technique and micro-catheters (2.9 Fr, Terumo Corporation, Tokyo, Japan). Then, the same three chemotherapeutic agents at the same dosages were used throughout this study, regardless of tumor number and size. Hepatic artery infusion chemotherapy was performed using carboplatin 300 mg. After that, chemolipiodolization was performed using epirubicin 50 mg, and mitomycin C 8 mg mixed with 5 mL of lipiodol. If the territory of the chemolipiodolized artery did not show stagnant flow, pure lipiodol was then injected. RFA was performed after TACE in 2 months by using a commercially available system (RF 2000; Radio-Therapeutics Mountain View, CA), and a needle electrode with a 15 Ga insulated cannula with 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; RadioTherapeutics).

Procedure: TACE+RFA

re-resection

ACTIVE COMPARATOR

Re-resection was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant and the possibility of a negative resection margin. We performed anatomical resection aiming at a resection margin of at least 1 cm. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 minutes and 5 minutes, respectively. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.

Procedure: re-resection

Interventions

TACE+RFA PROCEDURE

TACE first, followed by RFA within 2 months

TACE+RFA

re-resection PROCEDURE

repeat hepatectomy for recurrent small HCC

Also known as: repeat hepatectomy

re-resection

Eligibility Criteria

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

You may qualify if:

• age 18 - 75 years;
• recurrence of HCC 12 months after initial hepatectomy;
• no other treatment received except for the initial hepatectomy;
• Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm
• lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
• no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3;
• Eastern Co-operative Oncology Group performance(ECOG) status 0 -1

You may not qualify if:

• the presence of vascular invasion or extrahepatic spread on imaging;
• a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
• an American Society of Anesthesiologists (ASA) score ≥ 3 -

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (4)

• Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.

  PMID: 23269991 BACKGROUND

• Peng ZW, Zhang YJ, Liang HH, Lin XJ, Guo RP, Chen MS. Recurrent hepatocellular carcinoma treated with sequential transcatheter arterial chemoembolization and RF ablation versus RF ablation alone: a prospective randomized trial. Radiology. 2012 Feb;262(2):689-700. doi: 10.1148/radiol.11110637. Epub 2011 Dec 12.

  PMID: 22157201 BACKGROUND

• Peng ZW, Guo RP, Zhang YJ, Lin XJ, Chen MS, Lau WY. Hepatic resection versus transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus. Cancer. 2012 Oct 1;118(19):4725-36. doi: 10.1002/cncr.26561. Epub 2012 Feb 22.

  PMID: 22359112 BACKGROUND

• Zhang YJ, Chen J, Zhou Z, Hu D, Wang J, Pan Y, Fu Y, Hu Z, Xu L, Chen MS. Transarterial Chemoembolization with Radiofrequency Ablation versus Surgical Resection for Small Late-Recurrence Hepatocellular Carcinoma. Radiology. 2025 Feb;314(2):e241096. doi: 10.1148/radiol.241096.

  PMID: 39903071 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• minshan chen, M.D.

  Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

minshan chen, M.D.

CONTACT

8620-87343117; chminsh@mail.sysu.edu.cn

yaojun zhang, M.D.

CONTACT

8620-87343121; zhyaojun@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 16, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2019
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

CN (1)