Combine TACE and RFA Versus RFA Monotherapy in Unilobar HCC of 3.1 to 7 cm Patient

NCT01858207 | Unknown Phase 2

• 1 other identifier: CMRPG3B0121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract of Research Proposal Radiofrequency ablation (RFA) has been proved to be a curative treatment with minimal invasiveness and high efficacy for small hepatocellular carcinoma (HCC) that is generally defined as maximal diameter no larger than 3cm. RFA can achieve a rate of complete necrosis as 80-100% in small HCC. However, the rate will drop to 71% in HCC of 3.1-5cm and 25% for HCC larger than 5cm。This is due to the relative hypervascularity for the bigger tumor and it will induce heat sink that leading to less effect of ablation. Therefore, transcatheter chemoembolization (TACE) before RFA may reduce the vascularity and enhance the effect of subsequent RFA. Moreover, pre-RF TACE will reduce the tumor size and the subsequent RFA will be more effective than RFA alone. In retrospective studies, Kitamoto M et al showed that tumor necrosis diameter was larger in TACE and RFA combination therapies compared to RFA mono-therapy; Yamakado K et al showed that TACE and RFA combination therapies in HCC (maximal diameter up to 12 cm) achieved 100% complete necrosis, 0% local recurrence rate and 93% of 2-year survival rate. Nevertheless, only one randomized trial in intermediate size HCC (3-5cm in diameter) showed that TACE and RFA combination therapies achieved a significant higher rate of complete necrosis, technique success, fewer treatment sessions to achieve complete necrosis and lower local recurrence but non-significant difference in 3-year survival rate. Therefore, based on the limited studies, combine TACE and RFA may achieve better effects than RFA mono-therapy in HCC larger than 3cm. However, repeat TACE may induce some complications such as HBV reactivation, hepatitis or even liver decompensation. Moreover, novel RFA using simultaneous multiple RFA probes with switching RF controller may achieve a better effects and shorter ablation time than sequential RFA with single electrode. Thus, is it still necessary using TACE and RFA combination therapies for HCC \>3cm when application of novel switching RF controller? The aim of the current study is to conduct a RCT comparing combine TACE and RFA compared to RFA mono-therapy by using simultaneous multiple electrodes and switching RF controller in uni-lobar HCC of 3.1-7cm. The rate of complete necrosis, technique success, sessions to achieve CN, local tumor progression, survival rate and major complications will be analyzed. Investigators cannot expect which one is better, safer before the achievement of the study.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; hepatocellular carcinoma; liver cancer

Outcome Measures

Primary Outcomes (1)

• The rate of complete necrosis (CN)

  The complete necrosis (or complete coagulation, complete necrosis, complete response) that is defined as persistent hypo-attenuation of the tumor on triphasic dynamic CT scan or MRI one month after the last ablation therapy. When no enhancing lesion was seen on CT after the initial ablation, primary technique effectiveness was considered to have been achieved. When lesion enhancement was still seen on CT, primary technique effectiveness was not considered as achieved. A course of treatment for each tumour was limited to three RF ablation sessions within 3 months

  2014 Dec (up to 3 years)

Secondary Outcomes (4)

• Primary technique effectiveness

  2014 Dec (up to 3 years)

• local tumor progression of HCC

  2014 Dec (up to 3 years)

• Survival

  2014 dec (up to 3 years)

• Major complication

  2014 Dec (up to 3 years)

Study Arms (2)

TACE+ RFA

ACTIVE COMPARATOR

This arm will be conventional TACE(Transcatheter Arterial Chemoembolization) plus RFA(radiofrequency ablation. use intra-injection of lipiodol mized with doxorubicin when the catheter was placed in the superselective location very close to the tumor.

Procedure: Transcatheter Arterial Chemoembolization; Drug: Doxorubicin

RFA

ACTIVE COMPARATOR

Recent advances in local ablation are aimed to expand the ablation size (\> 3cm in diameter) in a minimal session by utilizing the switching RF controller and simultaneous 2 or 3 RF electrodes placement. The procedure of RFA was according to manufacture algorithm. RFA was performed within 7 days after TACE because the embolization effect in reducing blood flow will be not evident afterwards.

Procedure: Radiofrequency ablation

Interventions

Transcatheter Arterial Chemoembolization PROCEDURE

traditional TACE, conventional TACE

Also known as: TACE, Chemoembolization

TACE+ RFA

Radiofrequency ablation PROCEDURE

simultaneous multiple electrodes and switching RF controller

Also known as: RFA

RFA

Doxorubicin DRUG

TACE will be done according to the current method in our center. We use intra-injection of lipiodol mized with doxorubicin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.

TACE+ RFA

Eligibility Criteria

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

You may qualify if:

• Age \>18 years;
• Unresectable HCC or patients with resectable HCC but not appropriate for resection;.
• Tumor stage: single tumor with 3.1-7cm in diameter, or multiple (maximum 3) tumors with at least one over 3cm but only one of the multiple tumors larger than 5cm for concerning too prolonged time of RFA. All the target tumors are located in single lobe.
• The lesion should be detected on ultrasonography;
• The divergence of the hepatic artery was suitable for TACE;
• Absence of portal and venous thrombosis, extrahepatic metastases, or uncontrollable ascites;
• Patients in Child-Pugh grade A or B;
• Eastern Cooperative Oncology Group performance status score of 2 or less;
• Patient has signed consent form regarding participation in the study.

You may not qualify if:

• Patients had previously received any treatment for HCC;
• Patients with known renal or cardiovascular disease before TACE;
• Child-Pugh grade C cirrhosis, prior decompensation and history of encephalopathy before TACE
• Pregnancy or plan to pregnant in the subsequent study period (1 to 2 years)

Sponsors & Collaborators

• Shi-Ming Lin: lead

Study Sites (1)

Chang Gung Memorial Hospital, Lin-Kuo

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Radiofrequency Ablation; Doxorubicin

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Shi-Ming Lin, MD

  Chang Gung Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi-Ming Lin, MD.

CONTACT

886-3-3281200; lsmpaicyto@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: May 11, 2013
• First Posted: May 21, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

TW (1)