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Completed

NCT Number: NCT04553458

Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency Ablation

Device

Radiofrequency ablation of the tumour

Trance-arterial chemoembolization

Drug

Trance-arterial chemotherapy

Other names: transcatheter arterial chemoembolization

liver resection

Procedure

non-anatomical or anatomical liver resection

Combined radiofrequency ablation + percutaneous ethanol injection

Combination Product

combined therapy

Percutaneous ethanol injection

Drug

Percutaneous ethanol injection of HCC

Other names: ETHANOL

systemic chemotherapy

Drug

Systemic chemotherapy

Other names: MIXED

Sorafenib

Drug

Sorafenib

Other names: NEXAVAR

Viscum

Dietary Supplement

Viscum for HCC

Symptomatic treatment

Drug

Symptomatic treatment

Other names: SUPPORTIVE

Primary outcomes

  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 outcomes

  1. DEATH (Number of patients died from the disease)

    Time frame: one-year

    Mortality rate

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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