Hepatocellular CarcinomaPhase 4TACE-RFANCT00556803
TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular Carcinoma
A Phase 4 study testing radiofrequency ablation and TACE after RFA in people with Hepatocellular Carcinoma and Liver Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- radiofrequency ablation and TACE after RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Jun 2010
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 75 years, and refused surgery
- A solitary HCC ≤ 7.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter
- Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
- No extrahepatic metastasis
- No imaging evidence of invasion into the major portal/hepatic vein branches
- No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
- A platelet count of > 40,000/mm3
- No previous treatment of HCC except liver resection
Who cannot join
- Patient compliance is poor
- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt so that TACE cannot be performed
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1). Any cancer curatively treated > 3 years prior to entry is permitted.
- History of cardiac disease:
- congestive heart failure > New York Heart Association (NYHA) class 2
- active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
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- cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin
- uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
- Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- Distantly extrahepatic metastasis
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- Excluded therapies and medications, previous and concomitant:
- Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to randomization.
- Prior use of systemic investigational agents for HCC
- Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Min-Shan Chen, M.D., Ph.D., 86-20-87343117, Chminsh@mail.sysu.edu.cn
About this study
Official title: Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.
Read the detailed description
Local ablation is a safe and effective therapy for patients who cannot undergo resection, or as a bridge to transplantation. Of the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for small HCC ≤ 5.0 cm, with a 3-year survival rate of 62% to 68%, a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%. Prospective randomized trials have shown RFA to be better than percutaneous ethanol injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of treatment sessions and better survival.
Unfortunately, the complete tumor necrosis rate for tumors larger than 5 cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5 cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA or adjacent microscopic satellite tumor nodules.
Transcatheter Arterial Chemoembolization (TACE) has proven to be an effective and palliative therapy for unresectable HCC. And some prospective randomized controlled trials have shown that adjuvant TACE after curative resection for HCC can improve the overall survivals and decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant therapy after RFA for HCC.
Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant therapy after RFA for HCC will improve the outcomes of RFA.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- radiofrequency ablation, TACE after RFA
- Keywords
- hepatocellular carcinoma, liver cancer, radiofrequency ablation, transcatheter arterial chemoembolization, adjuvant therapy
- 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.
radiofrequency ablationProcedure or surgery
Also called RFA
radiofrequency ablation
TACE after RFAProcedure or surgery
Also called TACE-RFA
TACE after RFA within one month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TACE after RFA within one month as an adjuvant therapy Receives: Procedure: TACE after RFA |
| 2 | Active comparator | RFA alone Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survivals
Measured: 3, and 5-years
Secondary outcomes (1)
Recurrence rates
Measured: 3, and 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Min-Shan Chen, M.D., Ph.D., Principal investigator, Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556803
- Sponsor's protocol ID
- rfa-003
- Acronym
- TACE-RFA
- Status last verified
- Nov 2008
- First submitted
- 9 Nov 2007
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.
PubMed 11923602Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.
PubMed 16495695Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.
PubMed 11419162
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00556803
- Acronym / sponsor ID
- TACE-RFA / rfa-003
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- hepatocellular carcinoma, liver cancer, radiofrequency ablation, transcatheter arterial chemoembolization, adjuvant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 12 Nov 2007 (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.
The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.
Detailed description
Local ablation is a safe and effective therapy for patients who cannot undergo resection, or as a bridge to transplantation. Of the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for small HCC ≤ 5.0 cm, with a 3-year survival rate of 62% to 68%, a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%. Prospective randomized trials have shown RFA to be better than percutaneous ethanol injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of treatment sessions and better survival.
Unfortunately, the complete tumor necrosis rate for tumors larger than 5 cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5 cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA or adjacent microscopic satellite tumor nodules.
Transcatheter Arterial Chemoembolization (TACE) has proven to be an effective and palliative therapy for unresectable HCC. And some prospective randomized controlled trials have shown that adjuvant TACE after curative resection for HCC can improve the overall survivals and decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant therapy after RFA for HCC.
Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant therapy after RFA for HCC will improve the outcomes of RFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: TACE after RFATACE after RFA within one month as an adjuvant therapy |
| 2 | Active comparator | Procedure: radiofrequency ablationRFA alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 - 75 years, and refused surgery
- A solitary HCC ≤ 7.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter
- Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
- No extrahepatic metastasis
- No imaging evidence of invasion into the major portal/hepatic vein branches
Key exclusion criteria (22 listed)
- Patient compliance is poor
- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt so that TACE cannot be performed
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1). Any cancer curatively treated > 3 years prior to entry is permitted.
- History of cardiac disease:
- Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
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 |
|---|---|---|
| radiofrequency ablationAlso: RFAradiofrequency ablation | Procedure or surgery | 2 |
| TACE after RFAAlso: TACE-RFATACE after RFA within one month | Procedure or surgery | 1 |
Primary outcome
Overall survivals
Time frame: 3, and 5-years
1 secondary outcome
Recurrence rates
Time frame: 3, and 5-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2008.
- Background: PubMed 11923602Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.
- Background: PubMed 16495695Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.
- Background: PubMed 11419162Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.
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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.
Min-Shan Chen, M.D., Ph.D. principal investigator
Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing radiofrequency ablation and TACE after RFA in people with Hepatocellular Carcinoma and Liver Cancer, run by Sun Yat-sen University at 1 site in China.
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 8 inclusion and 22 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 18 Nov 2008. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Min-Shan Chen, M.D, Ph.D (86-20-87343117, Chminsh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survivals (time frame: 3, and 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556803, which also lists 3 linked publications.
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 18 Nov 2008.