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Combine Chemoembolization and Radiofrequency Ablation Versus Radiofrequency Ablation Monotherapy for Patients With Unilobar Hepatocellular Carcinoma of 3.1 to 7 cm: A Randomized Controlled Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Combine Chemoembolization and Radiofrequency Ablation Versus Radiofrequency Ablation Monotherapy for Patients With Unilobar Hepatocellular Carcinoma of 3.1 to 7 cm: A Randomized Controlled Trial


Specific Aims:

The aim of the current study is to compare TACE and RFA combination therapies with RFA
mono-therapy by using simultaneous multiple electrodes and switching RF controller in the
treatment of uni-lobar HCC of 3.1 to 7cm. The rate of complete necrosis (CN), technique
success, sessions to achieve CN, local tumor progression, survival rate and major
complications will be analyzed.

Background:

HCC is 4th mostly common malignancy worldwide and the leading cause of cancer-death in
Taiwan.

Surveillance programs can detect HCC at early stage. Surgical resection, liver
transplantation and local ablation are currently considered as curative treatment modalities
for early stage HCC. However, only 10-30% of early stage HCC is suitable for resection due
to poor liver reserve, co-morbidity and shortage of liver donor. Therefore, local ablation
plays an important role in the treatment of unresectable or resectable early-stage HCC.
Among the various local ablative modalities, radiofrequency ablation (RFA) has been proved
to be a curative treatment with minimal invasiveness and high efficacy for small 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 > 5cm。 The difference 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 to unembolized viable tumor will be more effective than RFA alone. In
retrospective studies, Kitamoto M et al showed that tumor necrosis diameter was larger in
combine TACE and RFA compared to RFA monotherapy; Yamakado K et al showed that combine TACE
and RFA 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 combine TACE and RFA achieved a
significant higher rate of technique success, fewer treatment sessions and lower local
recurrence but non-significant 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? 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, sessions to achieve CN, primary
technique effectiveness (i.e. achievement of complete necrosis after maximum of 3 treatment
sessions), local tumor progression, survival rate and major complications will be analyzed.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The rate of complete necrosis (CN)

Outcome Description:

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

Outcome Time Frame:

2014 Dec (up to 3 years)

Safety Issue:

No

Principal Investigator

Shi-Ming Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chang Gung Medical Foundation

Authority:

Taiwan: Institutional Review Board

Study ID:

CMRPG3B0121

NCT ID:

NCT01858207

Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • hepatocellular carcinoma
  • liver cancer
  • Carcinoma
  • Carcinoma, Hepatocellular

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