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Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04553458
Enrollment
407
Registered
2020-09-17
Start date
2015-06-30
Completion date
2020-06-30
Last updated
2020-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, HCC, Hepatoma, primary liver tumours

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.

Interventions

DEVICERadiofrequency ablation

Radiofrequency ablation of the tumour

DRUGTrance-arterial chemoembolization

Trance-arterial chemotherapy

PROCEDURELiver resection

non-anatomical or anatomical liver resection

COMBINATION_PRODUCTCombined radiofrequency ablation + percutaneous ethanol injection

combined therapy

Percutaneous ethanol injection of HCC

DRUGSystemic chemotherapy

Systemic chemotherapy

DRUGSorafenib

Sorafenib

DIETARY_SUPPLEMENTViscum

Viscum for HCC

Symptomatic treatment

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CURE (Number of patients cured completely from the disease)one-yearthe HCC is treated (disappearance of all lesions)
STABLE Disease (Number of patients with neither progression nor cure from the disease)one-yearNONE 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 lesionsone-yearincrease in size - appearance of new intratumoral lesions - new lesions

Secondary

MeasureTime frameDescription
DEATH (Number of patients died from the disease)one-yearMortality rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026