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Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT04553458
Recruitment Status : Completed
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Emad Ali Ahmed Ali, Sohag University

Study Description
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Brief 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 were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Device: Radiofrequency ablation Drug: Trance-arterial chemoembolization Procedure: Liver resection Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection Drug: Percutaneous ethanol injection Drug: Systemic chemotherapy Drug: Sorafenib Dietary Supplement: Viscum Drug: Symptomatic 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 Design
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Study Type : Observational
Actual Enrollment : 407 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma
Actual Study Start Date : June 2015
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020
Groups and Cohorts
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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 Name: 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 Name: ETHANOL
Unfavorable outcome
Progressive (deteriorate/Recurrence) or Death
 Device: Radiofrequency ablation
Radiofrequency ablation of the tumour

Drug: Trance-arterial chemoembolization
Trance-arterial chemotherapy
Other Name: transcatheter arterial chemoembolization

Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection
combined therapy

Drug: Percutaneous ethanol injection
Percutaneous ethanol injection of HCC
Other Name: ETHANOL

Drug: Systemic chemotherapy
Systemic chemotherapy
Other Name: MIXED

Drug: Sorafenib
Sorafenib
Other Name: NEXAVAR

Dietary Supplement: Viscum
Viscum for HCC

Drug: Symptomatic treatment
Symptomatic treatment
Other Name: SUPPORTIVE


Outcome Measures
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Primary Outcome Measures :
  1. CURE (Number of patients cured completely from the disease) [ Time Frame: one-year ]
    the HCC is treated (disappearance of all lesions)

  2. STABLE Disease (Number of patients with neither progression nor cure from the disease) [ Time Frame: one-year ]
    NONE of the other outcomes' criteria

  3. 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


Secondary Outcome Measures :
  1. DEATH (Number of patients died from the disease) [ Time Frame: one-year ]
    Mortality rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553458


Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Emad A. Ahmed, MD, PhD Sohag University
More Information
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Responsible Party: Emad Ali Ahmed Ali, Principal investigator, Sohag University
ClinicalTrials.gov Identifier: NCT04553458    
Other Study ID Numbers: 22/09/2020
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emad Ali Ahmed Ali, Sohag University:
Hepatocellular carcinoma
HCC
Hepatoma
primary liver tumours
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
 Ethanol
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs