Hepatocellular CarcinomaPhase 2NCT01858207
Combine TACE and RFA Versus RFA Monotherapy in Unilobar HCC of 3.1 to 7 cm Patient
A Phase 2 study testing Transcatheter Arterial Chemoembolization, Radiofrequency ablation and Doxorubicin in people with Hepatocellular Carcinoma, run by Shi-Ming Lin at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transcatheter Arterial Chemoembolization, Radiofrequency ablation and Doxorubicin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Lin-Kuo
Taoyuan
Yu-Ray Chen, +886-2-27135211
Shih-Ming Lin, MD.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transcatheter Arterial Chemoembolization, Radiofrequency ablation, Doxorubicin
- Keywords
- HCC, hepatocellular carcinoma, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial ChemoembolizationProcedure or surgery
Also called TACE, Chemoembolization
traditional TACE, conventional TACE
Radiofrequency ablationProcedure or surgery
Also called RFA
simultaneous multiple electrodes and switching RF controller
DoxorubicinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2014 Dec (up to 3 years)
Secondary outcomes (4)
Primary technique effectiveness
i.e. achievement of complete necrosis after maximum of 3 treatment sessions. 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.
Measured: 2014 Dec (up to 3 years)
local tumor progression of HCC
this was defined as the appearance of nodular enhancement contiguous with the ablated tumor on dynamic imaging or an increase in the size of the ablated area on follow-up imaging of a tumor that was previously completely ablated.
Measured: 2014 Dec (up to 3 years)
Survival
That was determined from the date of RF ablation to that of last follow-up or death.
Measured: 2014 dec (up to 3 years)
Major complication
that was defined as those requiring treatment with hospitalization or involving permanent adverse sequelae.
Measured: 2014 Dec (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi-Ming Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi-Ming Lin, Chang Gung Memorial Hospital
- Investigators
- Shi-Ming Lin, MD, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858207
- Sponsor's protocol ID
- CMRPG3B0121
- Status last verified
- May 2013
- First submitted
- 11 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01858207
- Acronym / sponsor ID
- CMRPG3B0121
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, hepatocellular carcinoma, liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shi-Ming LinUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+ RFA | Active comparator | Procedure: Transcatheter Arterial Chemoembolization, Drug: DoxorubicinThis 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. |
| RFA | Active comparator | Procedure: Radiofrequency ablationRecent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Arterial ChemoembolizationAlso: TACE, Chemoembolizationtraditional TACE, conventional TACE | Procedure or surgery | TACE+ RFA |
| Radiofrequency ablationAlso: RFAsimultaneous multiple electrodes and switching RF controller | Procedure or surgery | RFA |
| DoxorubicinTACE 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. | Drug | TACE+ RFA |
Primary outcome
The rate of complete necrosis (CN)
Time frame: 2014 Dec (up to 3 years)
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
4 secondary outcomes
Primary technique effectiveness
Time frame: 2014 Dec (up to 3 years)
local tumor progression of HCC
Time frame: 2014 Dec (up to 3 years)
Survival
Time frame: 2014 dec (up to 3 years)
Major complication
Time frame: 2014 Dec (up to 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi-Ming Lin, MD principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcatheter Arterial Chemoembolization, Radiofrequency ablation and Doxorubicin in people with Hepatocellular Carcinoma, run by Shi-Ming Lin at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi-Ming Lin, MD. (886-3-3281200 ext. 8107, lsmpaicyto@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of complete necrosis (CN) (time frame: 2014 Dec (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.