Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Favorable outcome<br>Cure or stable disease | Device: Radiofrequency ablation<br>* Radiofrequency ablation of the tumour<br>Drug: Trance-arterial chemoembolization<br>* Trance-arterial chemotherapy<br>* Other names: transcatheter arterial chemoembolization;Procedure: Liver resection<br>* non-anatomical or anatomical liver resection<br>Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection<br>* combined therapy<br>Drug: Percutaneous ethanol injection<br>* Percutaneous ethanol injection of HCC<br>* Other names: ETHANOL;|
| Unfavorable outcome<br>Progressive (deteriorate/Recurrence) or Death | Device: Radiofrequency ablation<br>* Radiofrequency ablation of the tumour<br>Drug: Trance-arterial chemoembolization<br>* Trance-arterial chemotherapy<br>* Other names: transcatheter arterial chemoembolization;Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection<br>* combined therapy<br>Drug: Percutaneous ethanol injection<br>* Percutaneous ethanol injection of HCC<br>* Other names: ETHANOL;Drug: Systemic chemotherapy<br>* Systemic chemotherapy<br>* Other names: MIXED;Drug: Sorafenib<br>* Sorafenib<br>* Other names: NEXAVAR;Dietary Supplement: Viscum<br>* Viscum for HCC<br>Drug: Symptomatic treatment<br>* Symptomatic treatment<br>* Other names: SUPPORTIVE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CURE (Number of patients cured completely from the disease) | the HCC is treated (disappearance of all lesions) | one-year | 
| STABLE Disease (Number of patients with neither progression nor cure from the disease) | NONE of the other outcomes' criteria | one-year | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEATH (Number of patients died from the disease) | Mortality rate | one-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, HCC, Hepatoma, primary liver tumours