Hepatocellular Carcinoma With Portal Vein Tumor ThrombusPhase 4NCT01600196
Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
A Phase 4 study testing Liver resection plus Thrombectomy in people with Hepatocellular Carcinoma With Portal Vein Tumor Thrombus, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- What is being tested?
- Liver resection plus Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Jul 2011
- 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
- The diagnosis of HCC was made according to AASLD guidelines
- Main tumor ≥ 7 cm
- Imaging confirmed the presence of PVTT in the first branches but not
- Extend into the main trunk of portal vein
- Eastern Co-operative Group performance
- Resectable disease
Who cannot join
- Child-Pugh class B or C liver cirrhosis
- An American Society of Anesthesiologists (ASA) score ≥ 3
- Extrahepatic metastasis
- Patients had access to sorafenib.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.
Read the detailed description
Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.
- Being tested
- Liver resection plus Thrombectomy
- Keywords
- Hepatectomy, Thrombectomy, Hepatocellular carcinoma, Portal vein tumor thrombus
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resection plus ThrombectomyProcedure or surgery
Also called Removal of all tumor tissue by surgery
Liver resection plus Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Resection arm | Experimental | Liver resection Plus Thrombectomy Receives: Procedure: Liver resection plus Thrombectomy |
| Best support care arm | No intervention | Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time
Measured: 5-years
Secondary outcomes (1)
Number of Adverse Events
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJan 2006
- Primary completionJul 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma With Portal Vein Tumor ThrombusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou 8th People's Hospital, Kaiping Central Hospital, The 458 Hospital of Chinese People's Liberation Army
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
- Investigators
- Ming Shi, MD., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600196
- Sponsor's protocol ID
- HCC2005009
- Status last verified
- Jan 2019
- First submitted
- 13 May 2012
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Le Treut YP, Hardwigsen J, Ananian P, Saisse J, Gregoire E, Richa H, Campan P. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg. 2006 Jun;10(6):855-62. doi: 10.1016/j.gassur.2005.12.011.
PubMed 16769542
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
- ClinicalTrials.gov ID
- NCT01600196
- Acronym / sponsor ID
- HCC2005009
- Keywords
- Hepatectomy, Thrombectomy, Hepatocellular carcinoma, Portal vein tumor thrombus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou 8th People's Hospital, Kaiping Central Hospital, The 458 Hospital of Chinese People's Liberation Army
- Study start
- Jan 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 May 2012 (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 evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.
Detailed description
Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resection arm | Experimental | Procedure: Liver resection plus ThrombectomyLiver resection Plus Thrombectomy |
| Best support care arm | No intervention | –Best supportive care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The diagnosis of HCC was made according to AASLD guidelines
- Main tumor ≥ 7 cm
- Imaging confirmed the presence of PVTT in the first branches but not
- Extend into the main trunk of portal vein
- Eastern Co-operative Group performance
Key exclusion criteria (4 listed)
- Child-Pugh class B or C liver cirrhosis
- An American Society of Anesthesiologists (ASA) score ≥ 3
- Extrahepatic metastasis
- Patients had access to sorafenib.
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 |
|---|---|---|
| Liver resection plus ThrombectomyAlso: Removal of all tumor tissue by surgeryLiver resection plus Thrombectomy | Procedure or surgery | Resection arm |
Primary outcome
Survival time
Time frame: 5-years
1 secondary outcome
Number of Adverse Events
Time frame: 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 16769542Le Treut YP, Hardwigsen J, Ananian P, Saisse J, Gregoire E, Richa H, Campan P. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg. 2006 Jun;10(6):855-62. doi: 10.1016/j.gassur.2005.12.011.
- web site of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.
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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 Shi, MD. principal investigator
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 Liver resection plus Thrombectomy in people with Hepatocellular Carcinoma With Portal Vein Tumor Thrombus, 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 6 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: stopped early, as of the sponsor's last update on 23 Jan 2019. 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?
The study was stopped early. Results are not available in the source record.
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?
Survival time (time frame: 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 NCT01600196, which also lists 1 linked publication.
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 Jan 2019.