Hepatocellular CarcinomaNCT05491889
Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization
An observational study of Hepatocellular Carcinoma, run by Assiut University.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth most common neoplasm worldwide and the third most frequent cause of death from cancer in the world. Hepatocellular carcinoma is responsible for significant morbidity and mortality in cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- trans arterial chemoembolization
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Feb 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patient with hepatocellular carcinoma with partial portal vein thrombosis
Who may be able to join
- Age > 18 years old
- HCC was diagnosed based on contrast imaging
- PPVT was diagnosed based on abdominal Duplex
Who cannot join
- Age < 18 years old
- Complete PVT
- Any previous therapy for HCC
- Extrahepatic concomitant malignancy
About this study
Hepatocellular carcinoma (HCC) is the fifth most common neoplasm worldwide and the third most frequent cause of death from cancer in the world. Hepatocellular carcinoma is responsible for significant morbidity and mortality in cirrhosis. Most cases of HCC occur in the setting of cirrhosis and, therefore, prognosis is determined not only by factors related to the tumor but also by factors related to cirrhosis (1).
According to previous reports, the incidence of HCC with partial portal vein thrombosis (PVTT) ranges between 44% and 62.2%. HCC associated with PVTT has a poor prognosis. It may lead to intrahepatic metastasis, liver dysfunction, and portal hypertension. The median overall survival for HCC patients with untreated PVTT is only 2.7 months (2).
Read more
It was suggested that HCC with PVTT should be classified as stage C based on Barcelona Clinic Liver Cancer; it is no longer surgically treatable. Compared with conservative treatment, TACE is a safe and effective therapy for such cases. However, this modality for treatment might be associated with mortality (3).
As far as we know, there is no studies of short-term survival in patients with HCC and PVT after TACE in our locality.
Our study aims to determine frequency of short-term mortality (< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.
Read the detailed description
Type of the study:cohort study Study Setting: Assiut University Hospitals
Sample Size Calculation:
Total coverage sample technique will be applied in the current study where all patients who are fulfilling inclusion criteria during the study period will be included.
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
For all the study patients, clinical evaluation (including demographic data and body mas index), laboratory investigations (including liver and kidney chemistry, INR, and complete blood picture), and imaging studies (including abdominal ultrasonography, doppler ultrasonography, and contrast computed tomography) will be provided.
CTP and MELD scores will be calculated.
Data management and analysis (Details needed):
Data collection: will include patients between 2015 and 2023. Computer software
Statistical tests:
Based on short term survival, eligible patients will be subdivided into two groups either survivors or non-survivors. Continuous data will be given in form of mean (SD) and compared by Student t test while nominal data will be expressed as frequency (percentage) and chi square test is used for such data.
Overall survival analysis will be done by Kaplan Meier survival curve. Logistic regression analysis will be applied to determine the possible predictors for short term mortality.
Level of confidence is kept at 95% and hence, p value is considered significant if < 0.05. Analysis of data will be done by SPSS 28 software
- Conditions
- Hepatocellular Carcinoma
- Being tested
- trans arterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans arterial chemoembolizationBiological
trans arterial chemoembolization in patient with partial portal vein thrombosis
| Study group | Role | What they receive |
|---|---|---|
| HCC patients with PPVT after TACE | determine frequency of short-term mortality (< 3month) among HCC patients with PPVT after TACE, and to explore its predictors. Receives: Biological: trans arterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
frequency of short term mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Eid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491889
- Sponsor's protocol ID
- 17101837
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all researcher will be blinded about data collection from other researchers.
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Zhang ZM, Lai EC, Zhang C, Yu HW, Liu Z, Wan BJ, Liu LM, Tian ZH, Deng H, Sun QH, Chen XP. The strategies for treating primary hepatocellular carcinoma with portal vein tumor thrombus. Int J Surg. 2015 Aug;20:8-16. doi: 10.1016/j.ijsu.2015.05.009. Epub 2015 May 27.
PubMed 26026424Xiang X, Lau WY, Wu ZY, Zhao C, Ma YL, Xiang BD, Zhu JY, Zhong JH, Li LQ. Transarterial chemoembolization versus best supportive care for patients with hepatocellular carcinoma with portal vein tumor thrombus：a multicenter study. Eur J Surg Oncol. 2019 Aug;45(8):1460-1467. doi: 10.1016/j.ejso.2019.03.042. Epub 2019 Apr 12.
PubMed 31005471
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization
- ClinicalTrials.gov ID
- NCT05491889
- Acronym / sponsor ID
- 17101837
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 8 Aug 2022 (actual)
- 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 neoplasm worldwide and the third most frequent cause of death from cancer in the world. Hepatocellular carcinoma is responsible for significant morbidity and mortality in cirrhosis. Most cases of HCC occur in the setting of cirrhosis and, therefore, prognosis is determined not only by factors related to the tumor but also by factors related to cirrhosis (1).
According to previous reports, the incidence of HCC with partial portal vein thrombosis (PVTT) ranges between 44% and 62.2%. HCC associated with PVTT has a poor prognosis. It may lead to intrahepatic metastasis, liver dysfunction, and portal hypertension. The median overall survival for HCC patients with untreated PVTT is only 2.7 months (2).
It was suggested that HCC with PVTT should be classified as stage C based on Barcelona Clinic Liver Cancer; it is no longer surgically treatable. Compared with conservative treatment, TACE is a safe and effective therapy for such cases. However, this modality for treatment might be associated with mortality (3).
As far as we know, there is no studies of short-term survival in patients with HCC and PVT after TACE in our locality.
Our study aims to determine frequency of short-term mortality (< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.
Detailed description
Type of the study:cohort study Study Setting: Assiut University Hospitals
Sample Size Calculation:
Total coverage sample technique will be applied in the current study where all patients who are fulfilling inclusion criteria during the study period will be included.
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
For all the study patients, clinical evaluation (including demographic data and body mas index), laboratory investigations (including liver and kidney chemistry, INR, and complete blood picture), and imaging studies (including abdominal ultrasonography, doppler ultrasonography, and contrast computed tomography) will be provided.
CTP and MELD scores will be calculated.
Data management and analysis (Details needed):
Data collection: will include patients between 2015 and 2023. Computer software
Statistical tests:
Based on short term survival, eligible patients will be subdivided into two groups either survivors or non-survivors. Continuous data will be given in form of mean (SD) and compared by Student t test while nominal data will be expressed as frequency (percentage) and chi square test is used for such data.
Overall survival analysis will be done by Kaplan Meier survival curve. Logistic regression analysis will be applied to determine the possible predictors for short term mortality.
Level of confidence is kept at 95% and hence, p value is considered significant if < 0.05. Analysis of data will be done by SPSS 28 software
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients with PPVT after TACE | – | Biological: trans arterial chemoembolizationdetermine frequency of short-term mortality (< 3month) among HCC patients with PPVT after TACE, and to explore its predictors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient with hepatocellular carcinoma with partial portal vein thrombosis
Key inclusion criteria (3 listed)
- Age > 18 years old
- HCC was diagnosed based on contrast imaging
- PPVT was diagnosed based on abdominal Duplex
Key exclusion criteria (4 listed)
- Age < 18 years old
- Complete PVT
- Any previous therapy for HCC
- Extrahepatic concomitant malignancy
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 |
|---|---|---|
| trans arterial chemoembolizationtrans arterial chemoembolization in patient with partial portal vein thrombosis | Biological | HCC patients with PPVT after TACE |
Primary outcome
mortality
Time frame: 3 months
frequency of short term mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 26026424Zhang ZM, Lai EC, Zhang C, Yu HW, Liu Z, Wan BJ, Liu LM, Tian ZH, Deng H, Sun QH, Chen XP. The strategies for treating primary hepatocellular carcinoma with portal vein tumor thrombus. Int J Surg. 2015 Aug;20:8-16. doi: 10.1016/j.ijsu.2015.05.009. Epub 2015 May 27.
- Background: PubMed 31005471Xiang X, Lau WY, Wu ZY, Zhao C, Ma YL, Xiang BD, Zhu JY, Zhong JH, Li LQ. Transarterial chemoembolization versus best supportive care for patients with hepatocellular carcinoma with portal vein tumor thrombus：a multicenter study. Eur J Surg Oncol. 2019 Aug;45(8):1460-1467. doi: 10.1016/j.ejso.2019.03.042. Epub 2019 Apr 12.
- Individual participant dataSharing planned: No. all researcher will be blinded about data collection from other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
mortality (time frame: 3 months). 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 NCT05491889, which also lists 3 linked publications.
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 8 Aug 2022.