Hepatocellular CarcinomaNCT04553458
Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Sohag University.
Trial summary
EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who… 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?
- Radiofrequency ablation, Trance-arterial chemoembolization and Liver resection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 407 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes.
Who may be able to join
- Adult patients
- with hepatocellular carcinoma
Who cannot join
- severely-ill patients
- With other system comorbidities,
- presence of extrahepatic metastasis,
- patients who dropped from the follow-up list after treatment.
About this study
EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.
Read the detailed description
Background:
EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.
Methods:
This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).
During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radiofrequency ablation, Trance-arterial chemoembolization, Liver resection, Combined radiofrequency ablation + percutaneous ethanol injection, Percutaneous ethanol injection
- Keywords
- Hepatocellular carcinoma, HCC, Hepatoma, primary liver tumours
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
Radiofrequency ablation of the tumour
Trance-arterial chemoembolizationDrug
Also called transcatheter arterial chemoembolization
Trance-arterial chemotherapy
Liver resectionProcedure or surgery
non-anatomical or anatomical liver resection
Combined radiofrequency ablation + percutaneous ethanol injectionCombination product
combined therapy
Percutaneous ethanol injectionDrug
Also called ETHANOL
Percutaneous ethanol injection of HCC
Systemic chemotherapyDrug
Also called MIXED
Systemic chemotherapy
SorafenibDrug
Also called NEXAVAR
Sorafenib
ViscumDietary supplement
Viscum for HCC
Symptomatic treatmentDrug
Also called SUPPORTIVE
Symptomatic treatment
| Study group | Role | What they receive |
|---|---|---|
| Favorable outcome | Cure or stable disease Receives: Device: Radiofrequency ablation; Drug: Trance-arterial chemoembolization; Procedure: Liver resection; Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection; Drug: Percutaneous ethanol injection | |
| Unfavorable outcome | Progressive (deteriorate/Recurrence) or Death Receives: Device: Radiofrequency ablation; Drug: Trance-arterial chemoembolization; Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection; Drug: Percutaneous ethanol injection; Drug: Systemic chemotherapy; Drug: Sorafenib; Dietary Supplement: Viscum; Drug: Symptomatic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
CURE (Number of patients cured completely from the disease)
the HCC is treated (disappearance of all lesions)
Measured: one-year
STABLE Disease (Number of patients with neither progression nor cure from the disease)
NONE of the other outcomes' criteria
Measured: one-year
PROGRESSIVE((Number of patients with progression of the disease) (measured by follow-up CT scans, increase in size, appearance of new intratumoral lesions, or appearance of new lesions
increase in size - appearance of new intratumoral lesions - new lesions
Measured: one-year
Secondary outcomes (1)
DEATH (Number of patients died from the disease)
Mortality rate
Measured: one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study startJun 2015
- Primary completionJun 2020
- Study completionJun 2020
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.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Ali Ahmed Ali, Sohag University
- Investigators
- Emad A. Ahmed, MD, PhD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553458
- Sponsor's protocol ID
- 22/09/2020
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04553458
- Acronym / sponsor ID
- 22/09/2020
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, HCC, Hepatoma, primary liver tumours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 17 Sep 2020 (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.
EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.
Detailed description
Background:
EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.
Methods:
This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).
During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favorable outcome | – | Device: Radiofrequency ablation, Drug: Trance-arterial chemoembolization, Procedure: Liver resection, Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection, Drug: Percutaneous ethanol injectionCure or stable disease |
| Unfavorable outcome | – | Device: Radiofrequency ablation, Drug: Trance-arterial chemoembolization, Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection, Drug: Percutaneous ethanol injection, Drug: Systemic chemotherapy, Drug: Sorafenib, Dietary Supplement: Viscum, Drug: Symptomatic treatmentProgressive (deteriorate/Recurrence) or Death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes.
Key inclusion criteria (2 listed)
- Adult patients
- with hepatocellular carcinoma
Key exclusion criteria (4 listed)
- severely-ill patients
- With other system comorbidities,
- presence of extrahepatic metastasis,
- patients who dropped from the follow-up list after treatment.
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 |
|---|---|---|
| Radiofrequency ablationRadiofrequency ablation of the tumour | Device | Favorable outcome, Unfavorable outcome |
| Trance-arterial chemoembolizationAlso: transcatheter arterial chemoembolizationTrance-arterial chemotherapy | Drug | Favorable outcome, Unfavorable outcome |
| Liver resectionnon-anatomical or anatomical liver resection | Procedure or surgery | Favorable outcome |
| Combined radiofrequency ablation + percutaneous ethanol injectioncombined therapy | Combination product | Favorable outcome, Unfavorable outcome |
| Percutaneous ethanol injectionAlso: ETHANOLPercutaneous ethanol injection of HCC | Drug | Favorable outcome, Unfavorable outcome |
| Systemic chemotherapyAlso: MIXEDSystemic chemotherapy | Drug | Unfavorable outcome |
| SorafenibAlso: NEXAVARSorafenib | Drug | Unfavorable outcome |
| ViscumViscum for HCC | Dietary supplement | Unfavorable outcome |
| Symptomatic treatmentAlso: SUPPORTIVESymptomatic treatment | Drug | Unfavorable outcome |
Primary outcome
CURE (Number of patients cured completely from the disease)
Time frame: one-year
the HCC is treated (disappearance of all lesions)
STABLE Disease (Number of patients with neither progression nor cure from the disease)
Time frame: one-year
NONE of the other outcomes' criteria
PROGRESSIVE((Number of patients with progression of the disease) (measured by follow-up CT scans, increase in size, appearance of new intratumoral lesions, or appearance of new lesions
Time frame: one-year
increase in size - appearance of new intratumoral lesions - new lesions
1 secondary outcome
DEATH (Number of patients died from the disease)
Time frame: one-year
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 17 Sep 2020.
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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.
Emad A. Ahmed, MD, PhD principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sohag 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 2 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: finished, as of the sponsor's last update on 17 Sep 2020. 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?
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?
CURE (Number of patients cured completely from the disease) (time frame: one-year). 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 17 Sep 2020.