Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553458
• Other study ID #: 22/09/2020
• Status: Completed
• Start date: June 2015
• Est. completion date: June 2020

Study information

• Verified date: September 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• Radiofrequency ablation
Radiofrequency ablation of the tumour

Drug:
• Trance-arterial chemoembolization
Trance-arterial chemotherapy

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
• Systemic chemotherapy
Systemic chemotherapy
• Sorafenib
Sorafenib

Dietary Supplement:
• Viscum
Viscum for HCC

Drug:
• Symptomatic treatment
Symptomatic treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CURE (Number of patients cured completely from the disease)	the HCC is treated (disappearance of all lesions)	one-year
Primary	STABLE Disease (Number of patients with neither progression nor cure from the disease)	NONE of the other outcomes' criteria	one-year
Primary	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	one-year
Secondary	DEATH (Number of patients died from the disease)	Mortality rate	one-year