Hepatocellular CarcinomaNCT02724475
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
A study testing LA and 3D-CRT in people with Hepatocellular Carcinoma and Laser Ablation, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Laser Ablation, Portal Vein Tumor Thrombus
- What is being tested?
- LA and 3D-CRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2015
- Phase
- Interventional
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Child-Pugh class B liver function；
- Preoperative ECOG criteria score of 0-2;
- Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
- Tumor thrombus in the second-order or more peripheral branch of portal vein;
- Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
- The expected survival time >6 months.
Who cannot join
- Other anticancer treatment before treatment
- Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
- Patients with other diseases that may affect the treatment of this treatment
- History of other malignant tumors
- Patients who are participating in other clinical trials
- Pregnant, lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled Trial
Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research.
- Being tested
- LA, 3D-CRT
- Keywords
- Laser Ablation, Portal Vein Tumor, Thrombus
- Medical subject headings
- Carcinoma, Hepatocellular, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAProcedure or surgery
Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated
3D-CRTProcedure or surgery
γ-knife treatment with radiation dose of 48-63 Gy/6-9 times
| Study group | Role | What they receive |
|---|---|---|
| LA group | Experimental | Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated. Receives: Procedure: LA |
| 3D-CRT group | Experimental | γ-knife treatment with radiation dose of 48-63 Gy/6-9 times. Receives: Procedure: 3D-CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxic and side effects caused by 3D-CRT or LA
Measured: 3 years
Postoperative complication
Measured: 3 years
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724475
- Sponsor's protocol ID
- 2012ZX10002016003
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02724475
- Acronym / sponsor ID
- 2012ZX10002016003
- Keywords
- Laser Ablation, Portal Vein Tumor, Thrombus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Mar 2016 (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.
Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA group | Experimental | Procedure: LAUltrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated. |
| 3D-CRT group | Experimental | Procedure: 3D-CRTγ-knife treatment with radiation dose of 48-63 Gy/6-9 times. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Child-Pugh class B liver function；
- Preoperative ECOG criteria score of 0-2;
- Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
- Tumor thrombus in the second-order or more peripheral branch of portal vein;
- Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
Key exclusion criteria (6 listed)
- Other anticancer treatment before treatment
- Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
- Patients with other diseases that may affect the treatment of this treatment
- History of other malignant tumors
- Patients who are participating in other clinical trials
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 |
|---|---|---|
| LAUltrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated | Procedure or surgery | LA group |
| 3D-CRTγ-knife treatment with radiation dose of 48-63 Gy/6-9 times | Procedure or surgery | 3D-CRT group |
Primary outcome
Toxic and side effects caused by 3D-CRT or LA
Time frame: 3 years
Postoperative complication
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LA and 3D-CRT in people with Hepatocellular Carcinoma and Laser Ablation, run by Eastern Hepatobiliary Surgery Hospital 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 6 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: finished, as of the sponsor's last update on 31 Mar 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxic and side effects caused by 3D-CRT or LA (time frame: 3 years). The study lists 3 primary outcomes in all. 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 31 Mar 2016.