Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

September 11, 2020 updated by: Emad Ali Ahmed Ali, Sohag University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
407

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Adult patients
  • with hepatocellular carcinoma

Exclusion Criteria:

  • severely-ill patients
  • With other system comorbidities,
  • presence of extrahepatic metastasis,
  • patients who dropped from the follow-up list after treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Favorable outcome
Cure or stable disease
Device: Radiofrequency ablation
Radiofrequency ablation of the tumour
Drug: Trance-arterial chemoembolization
Trance-arterial chemotherapy
Other Names:
  • transcatheter arterial chemoembolization
Procedure: Liver resection
non-anatomical or anatomical liver resection
Combination product: Combined radiofrequency ablation + percutaneous ethanol injection
combined therapy
Drug: Percutaneous ethanol injection
Percutaneous ethanol injection of HCC
Other Names:
  • ETHANOL
Unfavorable outcome
Progressive (deteriorate/Recurrence) or Death
Drug: Sorafenib
Sorafenib
Other Names:
  • NEXAVAR
Device: Radiofrequency ablation
Radiofrequency ablation of the tumour
Drug: Trance-arterial chemoembolization
Trance-arterial chemotherapy
Other Names:
  • transcatheter arterial chemoembolization
Combination product: Combined radiofrequency ablation + percutaneous ethanol injection
combined therapy
Drug: Percutaneous ethanol injection
Percutaneous ethanol injection of HCC
Other Names:
  • ETHANOL
Drug: Systemic chemotherapy
Systemic chemotherapy
Other Names:
  • MIXED
Dietary supplement: Viscum
Viscum for HCC
Drug: Symptomatic treatment
Symptomatic treatment
Other Names:
  • SUPPORTIVE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CURE (Number of patients cured completely from the disease)
Time Frame: one-year
the HCC is treated (disappearance of all lesions)
one-year
STABLE Disease (Number of patients with neither progression nor cure from the disease)
Time Frame: one-year
NONE of the other outcomes' criteria
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
Time Frame: one-year
increase in size - appearance of new intratumoral lesions - new lesions
one-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DEATH (Number of patients died from the disease)
Time Frame: one-year
Mortality rate
one-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emad A. Ahmed, MD, PhD, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/09/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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