HepatoCellular CarcinomaRHCCNCT02309788
Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis
An observational study of HepatoCellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~ 50% in advanced HCC and it is now become… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HepatoCellular Carcinoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with HCC at the Affiliated Tumor Hospital of Guangxi Medical University Science were considered for enrollment in the study. The diagnostic criteria for HCC used in the study were in accordance with the American Association for the Study of Liver Diseases' 2005 guidelines. All patients had preoperative serum a-fetoprotein (AFP) levels >200 ng/mL or a typical enhancement pattern (arterial enhancement and portal/delayed washed out) on dynamic imaging of hepatic mass(es)>2 cm, or cytologic/histologic evidence of HCC
Who may be able to join
- HCC with no preoperative RT
- resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function
- compensated cirrhosis or no cirrhosis; Child-Pugh A
- ECOG Performance Status of 0 or 1.
- Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry
Who cannot join
- unresectable hepatocellular carcinoma patients
- Hepatocellular carcinoma without portal vein tumor thrombus
- Hepatectomy without narrow margin(more than 1cm)
- presence of distant metastasis
- palliative resection with tumor residual
- non-HCC confirmed by postoperative pathology
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TaoBai
Nanning, Guangxi, 530000
Tao Bai, MD, +86 13878862632, 25859373@qq.com
About this study
Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~ 50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor recurrence.
- Conditions
- HepatoCellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RT | Resectable HCC patients adjuvant RT for PVT or NM | |
| No RT | Resectable HCC patients adjuvant other treatment for PVT or NM |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionDec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TaoBai, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309788
- Sponsor's protocol ID
- TAOBAI
- Acronym
- RHCC
- Status last verified
- Jan 2016
- First submitted
- 2 Dec 2014
- Last updated
- 26 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02309788
- Acronym / sponsor ID
- RHCC / TAOBAI
- Conditions
- HepatoCellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- First posted
- 5 Dec 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.
Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~ 50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT | – | –Resectable HCC patients adjuvant RT for PVT or NM |
| No RT | – | –Resectable HCC patients adjuvant other treatment for PVT or NM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with HCC at the Affiliated Tumor Hospital of Guangxi Medical University Science were considered for enrollment in the study. The diagnostic criteria for HCC used in the study were in accordance with the American Association for the Study of Liver Diseases' 2005 guidelines. All patients had preoperative serum a-fetoprotein (AFP) levels >200 ng/mL or a typical enhancement pattern (arterial enhancement and portal/delayed washed out) on dynamic imaging of hepatic mass(es)>2 cm, or cytologic/histologic evidence of HCC
Key inclusion criteria (5 listed)
- HCC with no preoperative RT
- resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function
- compensated cirrhosis or no cirrhosis; Child-Pugh A
- ECOG Performance Status of 0 or 1.
- Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry
Key exclusion criteria (6 listed)
- unresectable hepatocellular carcinoma patients
- Hepatocellular carcinoma without portal vein tumor thrombus
- Hepatectomy without narrow margin(more than 1cm)
- presence of distant metastasis
- palliative resection with tumor residual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HepatoCellular Carcinoma, run by Guangxi Medical 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 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: status not confirmed, as of the sponsor's last update on 26 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bai Tao, MD (+86 18507712632, 25859373@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 1year). 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 26 Jan 2016.