Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Radiofrequency ablation; Drug: Trance-arterial chemoembolization; Procedure: Liver resection; Drug: Percutaneous ethanol injection; Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection; Drug: Systemic chemotherapy; Drug: Sorafenib; Dietary Supplement: Viscum; Drug: Symptomatic treatment

• Registration Number: NCT04553458
• Lead Sponsor: Sohag University

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.

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 Timeline

• Study Start: 2015-06
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-09
• Study First Submitted: 2020-09-05
• Study First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unfavorable outcome	Percutaneous ethanol injection	Progressive (deteriorate/Recurrence) or Death
Favorable outcome	Radiofrequency ablation	Cure or stable disease
Favorable outcome	Trance-arterial chemoembolization	Cure or stable disease
Favorable outcome	Liver resection	Cure or stable disease
Favorable outcome	Percutaneous ethanol injection	Cure or stable disease
Unfavorable outcome	Systemic chemotherapy	Progressive (deteriorate/Recurrence) or Death
Favorable outcome	Combined radiofrequency ablation + percutaneous ethanol injection	Cure or stable disease
Unfavorable outcome	Radiofrequency ablation	Progressive (deteriorate/Recurrence) or Death
Unfavorable outcome	Combined radiofrequency ablation + percutaneous ethanol injection	Progressive (deteriorate/Recurrence) or Death
Unfavorable outcome	Viscum	Progressive (deteriorate/Recurrence) or Death
Unfavorable outcome	Symptomatic treatment	Progressive (deteriorate/Recurrence) or Death
Unfavorable outcome	Trance-arterial chemoembolization	Progressive (deteriorate/Recurrence) or Death
Unfavorable outcome	Sorafenib	Progressive (deteriorate/Recurrence) or Death

Primary Outcome Measures

Name	Time	Method
CURE (Number of patients cured completely from the disease)	one-year	the HCC is treated (disappearance of all lesions)
STABLE Disease (Number of patients with neither progression nor cure from the disease)	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	one-year	increase in size - appearance of new intratumoral lesions - new lesions

Secondary Outcome Measures

Name	Time	Method
DEATH (Number of patients died from the disease)	one-year	Mortality rate