Hepatocellular CarcinomaPhase 3CORTTNCT02301091
Combine TACE and RFA Versus TACE Alone for HCC With PVTT
A Phase 3 study testing TACE, RFA and pirarubicin,mitomycin and lobaplatin in people with Hepatocellular Carcinoma, run by Ming Zhao at 1 site in China.
Trial summary
The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE, RFA and pirarubicin,mitomycin and lobaplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2019
- Phase
- Phase 3
- 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
- HCC with portal vein tumor thrombus in the first or second branch
- Refused sorafenib or could not tolerate the adverse effect of sorafenib
- A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter
- Eastern Cooperative Oncology Group Performance Status 0-1
- Child-Pugh Score ≤ 8
- A platelet counts of > 60,000/mm3, hemoglobin>8.5 g/dL, prothrombin time prolong <6s
- Albumin >2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit
- Sign the informed consent.
Who cannot join
- Presence of extrahepatic metastasis except lymph node metastasis
- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
- Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
- Severe heart, brain or kidney diseases
- Previous or concurrent cancer that is distinct in primary site or histology from HCC
- Pregnant women or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 500060
Ming Zhao, doctor, +86 020 87343272, zhaoming@sysucc.org.cn
About this study
Official title: Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.
Read the detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second most common cause of death from cancer globally. Although the development of imaging techniques has improved early HCC diagnosis, portal vein tumor thrombus (PVTT) is still identified in 12.5-39.7% of HCC patients at their initial visits. Patients suffering from extremely aggressive HCC with PVTT have a median survival time of only 2.7-4.0 months if left untreated. The current standard of practice recommends sorafenib, which has been shown to prolong overall survival (OS) by nearly 3 months in advanced HCC patients and by 1.5-3.2 months in those with PVTT.
Transarterial chemoembolization (TACE) is the main treatment modality for unresectable HCC patients. Some recent prospective studies have demonstrated that TACE can serve as a safe and effective procedure in selected HCC patients with PVTT. TACE is recommend for a part of patients with HCC and PVTT by the treatment guidelines in China and Japan. However,due to the poor blood supplement of PVTT,the local control rate of PVTT after TACE treatment is low. Besides,as to some hypovascular intrahepatic tumors, TACE also could not controlled effectively. As regard to the high local control rate of radiofrequency ablation (RFA) for intrahepatic lesions and PVTT reported in some studies, we thus suggested that the combination of TACE and RFA might have higher tumor control rate and survival benefit than TACE alone.
We design this study to compare survival outcomes of TACE plus RFA and TACE alone in patients with HCC and PVTT.A total of 240 patients are needed according to statistician's calculation.They will be divided into two groups randomly by computer after sign the informed consent form.One group of patients received TACE plus RFA and the other group of patients received TACE alone.After treatment,patients will be followed-up on their survival, tumor response and adverse events.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE, RFA, pirarubicin,mitomycin and lobaplatin
- Keywords
- HCC PVTT TACE RFA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called Transcatheter Arterial Chemoembolization, Chemoembolization
TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin 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.
RFAProcedure or surgery
Also called Radiofrenquency ablation, RF ablation
For RFA, we used two commercially available system (Cool-Tip, Valleylab，USA) and (Octopus RF Systema，Starmed,Korea）with needle electrode with a 17-gauge internally cooled electrode.
pirarubicin,mitomycin and lobaplatinDrug
Also called cytotoxic drugs
They were cytotoxic drugs used in the TACE procedure.
| Study group | Role | What they receive |
|---|---|---|
| TACE-RFA | Experimental | 2 times TACE first, RFA for residual viable tumors and PVTT within 1 month. Receives: Procedure: TACE; Procedure: RFA; Drug: pirarubicin,mitomycin and lobaplatin |
| TACE alone | Active comparator | repeated TACE and 1 to 2 months interval between two sessions of TACE. Receives: Procedure: TACE; Drug: pirarubicin,mitomycin and lobaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rates
Measured: 1 year
Secondary outcomes (3)
Progression-free survival rates
Measured: 6 months
Response rate of PVTT
Measured: 6 months
Number of participants with adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Zhao, Sun Yat-sen University
- Investigators
- Ming Zhao, doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301091
- Sponsor's protocol ID
- 2014-FXY-036
- Acronym
- CORTT
- Status last verified
- Apr 2016
- First submitted
- 13 Nov 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT02301091
- Acronym / sponsor ID
- CORTT / 2014-FXY-036
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC PVTT TACE RFA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ming ZhaoUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 25 Nov 2014 (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 determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.
Detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second most common cause of death from cancer globally. Although the development of imaging techniques has improved early HCC diagnosis, portal vein tumor thrombus (PVTT) is still identified in 12.5-39.7% of HCC patients at their initial visits. Patients suffering from extremely aggressive HCC with PVTT have a median survival time of only 2.7-4.0 months if left untreated. The current standard of practice recommends sorafenib, which has been shown to prolong overall survival (OS) by nearly 3 months in advanced HCC patients and by 1.5-3.2 months in those with PVTT.
Transarterial chemoembolization (TACE) is the main treatment modality for unresectable HCC patients. Some recent prospective studies have demonstrated that TACE can serve as a safe and effective procedure in selected HCC patients with PVTT. TACE is recommend for a part of patients with HCC and PVTT by the treatment guidelines in China and Japan. However,due to the poor blood supplement of PVTT,the local control rate of PVTT after TACE treatment is low. Besides,as to some hypovascular intrahepatic tumors, TACE also could not controlled effectively. As regard to the high local control rate of radiofrequency ablation (RFA) for intrahepatic lesions and PVTT reported in some studies, we thus suggested that the combination of TACE and RFA might have higher tumor control rate and survival benefit than TACE alone.
We design this study to compare survival outcomes of TACE plus RFA and TACE alone in patients with HCC and PVTT.A total of 240 patients are needed according to statistician's calculation.They will be divided into two groups randomly by computer after sign the informed consent form.One group of patients received TACE plus RFA and the other group of patients received TACE alone.After treatment,patients will be followed-up on their survival, tumor response and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE-RFA | Experimental | Procedure: TACE, Procedure: RFA, Drug: pirarubicin,mitomycin and lobaplatin2 times TACE first, RFA for residual viable tumors and PVTT within 1 month. |
| TACE alone | Active comparator | Procedure: TACE, Drug: pirarubicin,mitomycin and lobaplatinrepeated TACE and 1 to 2 months interval between two sessions of TACE. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HCC with portal vein tumor thrombus in the first or second branch
- Refused sorafenib or could not tolerate the adverse effect of sorafenib
- A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter
- Eastern Cooperative Oncology Group Performance Status 0-1
- Child-Pugh Score ≤ 8
Key exclusion criteria (6 listed)
- Presence of extrahepatic metastasis except lymph node metastasis
- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
- Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
- Severe heart, brain or kidney diseases
- Previous or concurrent cancer that is distinct in primary site or histology from HCC
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 |
|---|---|---|
| TACEAlso: Transcatheter Arterial Chemoembolization, ChemoembolizationTACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin 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. | Procedure or surgery | TACE alone, TACE-RFA |
| RFAAlso: Radiofrenquency ablation, RF ablationFor RFA, we used two commercially available system (Cool-Tip, Valleylab，USA) and (Octopus RF Systema，Starmed,Korea）with needle electrode with a 17-gauge internally cooled electrode. | Procedure or surgery | TACE-RFA |
| pirarubicin,mitomycin and lobaplatinAlso: cytotoxic drugsThey were cytotoxic drugs used in the TACE procedure. | Drug | TACE alone, TACE-RFA |
Primary outcome
Overall survival rates
Time frame: 1 year
3 secondary outcomes
Progression-free survival rates
Time frame: 6 months
Response rate of PVTT
Time frame: 6 months
Number of participants with adverse events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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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.
Ming Zhao, doctor principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TACE, RFA and pirarubicin,mitomycin and lobaplatin in people with Hepatocellular Carcinoma, run by Ming Zhao 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 6 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 14 Apr 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ming Zhao, doctor (+86 020 87343272, zhaoming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rates (time frame: 1 year). 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 14 Apr 2016.