Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Sohag University

Status: Completed

Conditions: Hepatocellular Carcinoma

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

Study type: Observational

Funder types: Other

Identifiers

NCT04553458

22/09/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

407 participants in 2 patient groups

Favorable outcome

Description:

Cure or stable disease

Treatment:

Procedure: Liver resection

Device: Radiofrequency ablation

Drug: Trance-arterial chemoembolization

Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection

Drug: Percutaneous ethanol injection

Unfavorable outcome

Description:

Progressive (deteriorate/Recurrence) or Death

Treatment:

Drug: Sorafenib

Device: Radiofrequency ablation

Drug: Trance-arterial chemoembolization

Dietary Supplement: Viscum

Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection

Drug: Percutaneous ethanol injection

Drug: Systemic chemotherapy

Drug: Symptomatic treatment