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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Sohag University

Investigators

  • 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)

June 1, 2015

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

September 5, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (ACTUAL)

September 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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