Hepatocellular CarcinomaPhase 2/3NCT00814242
Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels
A Phase 2/3 study testing surgical resection and percutaneous radiationfrequency ablation in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
This study will compare and analyze the difference between hepatectomy at deep and complex sites(adjacent to major blood vessels) of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence of complications so as to establish treatment standards of HCC at these sites. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- surgical resection and percutaneous radiationfrequency ablation
- 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
- Dec 2008to Nov 2011
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify patients with HCC in accordance with the clinical diagnostic criteria of HCC passed at the Chines Eighth National Live Cancer Academic Conference. Patients with HCC shall be diagnosed with pathology. There is at least one measurable lesion.
- Hepatoma involved in this research at complex site is located at the eighth segment of liver, the substantial depth of liver below hepatic integument adjacent to the trunk of inferior vena cava, hepatic vein and portal vein. The tumor is located at hepatic caudate lobe. The maximal diameter < or=3m, AJCC/UICC-TNM stage is stage II and above. Lesions are determined by three senior hepatobiliary experts independently, therefore radical resection is possible. There is no possibility of extra-hepatic metastasis and tumor thrombus of portal vein, hepatic vein, vena cava and bile duct.
- Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. It's appropriate to perform liver resection and minimally invasive treatment.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
- Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.
Who cannot join
- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Women in pregnancy and breast-feeding.
- Patients with tumor AJCC/UICC-TNM stage at IIIA period or below.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels
This study will compare and analyze the difference between hepatectomy at deep and complex sites(adjacent to major blood vessels) of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence of complications so as to establish treatment standards of HCC at these sites.
Read the detailed description
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying. In recent years, lots of clinical practice and a small amount of evidence-based medicine show that: ①.Surgical treatment is still the preferred choice of the treatment of HCC. ②. The standardization of comprehensive treatment should be put in top priority in current treatment of HCC. Rational treatment methods should be adopted in accordance with specific conditions of patients. The best and latest treatment methods should also be provided to improve the efficacy to the largest extent for the benefit of the majority of patients with HCC.
Today, tumor remaining in a patient after therapy with curative intent(eg. surgical resection for cure ) is categorized by a system known as R classification. That is shown: RX: presence of residual tumor can not be assessed; R0: no residual tumor; R1: microscopic residual tumor; R2: macroscopic residual tumor; The residue with the application of R classification not only refers to both residual tumor at the margin of surgical excision but also residue in distant metastasis. The higher R classification is, the worse the prognosis becomes.
Most studies have been leaded a good result By now that percutaneous radiationfrequency ablation(PRFA) is efficacious and safe for patients with HCC. In patients with HCC smaller than 3cm, PRFA may be comparable to suegical resection in long-term outcome.
At present, radical resection (for the final R0 or R1) performed in HCC at most deep and complex sites (including caudate lobe HCC, 8th segment hepatoma adjacent to the trunk of inferior vena cava, hepatic vein and portal vein, etc) often lead to serious damage to major blood vessels (i.e., hepatic vein, short hepatic vein, portal vein and inferior vena cava) and hemorrhage during surgery. Therefore, when the surgeon performs surgery near major sites, he should excise as few normal liver tissues as possible to avoid above-mentioned hazard. However, the resection margin may not be complete and thus affect radical effect. In addition, as the tumor is rather deep located, lots of normal liver tissues on the surface of the tumor are excised with massive bleeding and serious damage. In view of this situation, the surgeon will adopt some alternatives (PRFA is rather common) to achieve the efficacy similar to liver excision and greatly reduce the risk of vascular injury and some complications like hepatic insufficiency. However, there are no studies on the efficacy comparison between this treatment method and the efficacy of liver excision, time to recurrence (TTR)stage, disease-free survival and overall survival condition.
This study will compare and analyze the difference between hepatectomy at deep and complex sites of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence of complications so as to establish treatment standards of HCC at these sites.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- surgical resection, percutaneous radiationfrequency ablation
- Keywords
- Hepatocellular Carcinoma, Adjacent to Major Blood Vessels, Surgical resection, Ppercutaneous radiationfrequency ablation, Time to recurrence, Disease-free survival, Overall survival
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical resectionProcedure or surgery
Also called hepatectomy group
radical resection performed in patinets with HCC.
percutaneous radiationfrequency ablationProcedure or surgery
Also called PRFA Goup
CT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC
| Study group | Role | What they receive |
|---|---|---|
| hepatectomy | Active comparator | Patients with HCC adjacent to major blood vessels recieved radical resection. Receives: Procedure: surgical resection |
| percutaneous radiationfrequency ablation | Experimental | CT or Ultrasound-guided percutaneous radiofrequency ablation Receives: Procedure: percutaneous radiationfrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor recurrence rate in one or two years; Disease-free survival;Overall survival.
Measured: 1,2,or 3 years
Secondary outcomes (1)
Overall survival rate in one, two，three or five years; Disease-free survival in one, two，three or five years; hepatic function of patients after surgery, the incidence rate of complications and the decline level of serum AFP concentration.
Measured: one, two，three or five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionNov 2011
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- Investigators
- Feng Shen, M.D., Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814242
- Sponsor's protocol ID
- EHBH-RCT-2008-009
- Status last verified
- Mar 2016
- First submitted
- 23 Dec 2008
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels
- ClinicalTrials.gov ID
- NCT00814242
- Acronym / sponsor ID
- EHBH-RCT-2008-009
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Adjacent to Major Blood Vessels, Surgical resection, Ppercutaneous radiationfrequency ablation, Time to recurrence, Disease-free survival, Overall survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Dec 2008 (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.
This study will compare and analyze the difference between hepatectomy at deep and complex sites(adjacent to major blood vessels) of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence of complications so as to establish treatment standards of HCC at these sites.
Detailed description
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying. In recent years, lots of clinical practice and a small amount of evidence-based medicine show that: ①.Surgical treatment is still the preferred choice of the treatment of HCC. ②. The standardization of comprehensive treatment should be put in top priority in current treatment of HCC. Rational treatment methods should be adopted in accordance with specific conditions of patients. The best and latest treatment methods should also be provided to improve the efficacy to the largest extent for the benefit of the majority of patients with HCC.
Today, tumor remaining in a patient after therapy with curative intent(eg. surgical resection for cure ) is categorized by a system known as R classification. That is shown: RX: presence of residual tumor can not be assessed; R0: no residual tumor; R1: microscopic residual tumor; R2: macroscopic residual tumor; The residue with the application of R classification not only refers to both residual tumor at the margin of surgical excision but also residue in distant metastasis. The higher R classification is, the worse the prognosis becomes.
Most studies have been leaded a good result By now that percutaneous radiationfrequency ablation(PRFA) is efficacious and safe for patients with HCC. In patients with HCC smaller than 3cm, PRFA may be comparable to suegical resection in long-term outcome.
At present, radical resection (for the final R0 or R1) performed in HCC at most deep and complex sites (including caudate lobe HCC, 8th segment hepatoma adjacent to the trunk of inferior vena cava, hepatic vein and portal vein, etc) often lead to serious damage to major blood vessels (i.e., hepatic vein, short hepatic vein, portal vein and inferior vena cava) and hemorrhage during surgery. Therefore, when the surgeon performs surgery near major sites, he should excise as few normal liver tissues as possible to avoid above-mentioned hazard. However, the resection margin may not be complete and thus affect radical effect. In addition, as the tumor is rather deep located, lots of normal liver tissues on the surface of the tumor are excised with massive bleeding and serious damage. In view of this situation, the surgeon will adopt some alternatives (PRFA is rather common) to achieve the efficacy similar to liver excision and greatly reduce the risk of vascular injury and some complications like hepatic insufficiency. However, there are no studies on the efficacy comparison between this treatment method and the efficacy of liver excision, time to recurrence (TTR)stage, disease-free survival and overall survival condition.
This study will compare and analyze the difference between hepatectomy at deep and complex sites of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence of complications so as to establish treatment standards of HCC at these sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatectomy | Active comparator | Procedure: surgical resectionPatients with HCC adjacent to major blood vessels recieved radical resection. |
| percutaneous radiationfrequency ablation | Experimental | Procedure: percutaneous radiationfrequency ablationCT or Ultrasound-guided percutaneous radiofrequency ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Identify patients with HCC in accordance with the clinical diagnostic criteria of HCC passed at the Chines Eighth National Live Cancer Academic Conference. Patients with HCC shall be diagnosed with pathology. There is at least one measurable lesion.
- Hepatoma involved in this research at complex site is located at the eighth segment of liver, the substantial depth of liver below hepatic integument adjacent to the trunk of inferior vena cava, hepatic vein and portal vein. The tumor is located at hepatic caudate lobe. The maximal diameter < or=3m, AJCC/UICC-TNM stage is stage II and above. Lesions are determined by three senior hepatobiliary experts independently, therefore radical resection is possible. There is no possibility of extra-hepatic metastasis and tumor thrombus of portal vein, hepatic vein, vena cava and bile duct.
- Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. It's appropriate to perform liver resection and minimally invasive treatment.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
- Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.
Key exclusion criteria (6 listed)
- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Women in pregnancy and breast-feeding.
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 |
|---|---|---|
| surgical resectionAlso: hepatectomy groupradical resection performed in patinets with HCC. | Procedure or surgery | hepatectomy |
| percutaneous radiationfrequency ablationAlso: PRFA GoupCT or Ultrasound-guided percutaneous radiofrequency ablation performed in patinets with HCC | Procedure or surgery | percutaneous radiationfrequency ablation |
Primary outcome
tumor recurrence rate in one or two years; Disease-free survival;Overall survival.
Time frame: 1,2,or 3 years
1 secondary outcome
Overall survival rate in one, two，three or five years; Disease-free survival in one, two，three or five years; hepatic function of patients after surgery, the incidence rate of complications and the decline level of serum AFP concentration.
Time frame: one, two，three or five 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 1 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.
Feng Shen, M.D. study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing surgical resection and percutaneous radiationfrequency ablation in people with Hepatocellular Carcinoma, 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 5 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 1 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 combined 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.
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?
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?
tumor recurrence rate in one or two years; Disease-free survival;Overall survival. (time frame: 1,2,or 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 1 Apr 2016.