Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

NCT04553458 | Completed DMC

• 1 other identifier: 22/09/2020
• Study Type: observational
• Target: 407
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; HCC; Hepatoma; primary liver tumours

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• DEATH (Number of patients died from the disease)

  one-year

Study Arms (2)

Favorable outcome

Cure or stable disease

Device: Radiofrequency ablation; Drug: Trance-arterial chemoembolization; Procedure: Liver resection; Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection; Drug: Percutaneous ethanol injection

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

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

Interventions

Radiofrequency ablation DEVICE

Radiofrequency ablation of the tumour

Favorable outcome; Unfavorable outcome

Trance-arterial chemoembolization DRUG

Trance-arterial chemotherapy

Also known as: transcatheter arterial chemoembolization

Favorable outcome; Unfavorable outcome

Liver resection PROCEDURE

non-anatomical or anatomical liver resection

Favorable outcome

Combined radiofrequency ablation + percutaneous ethanol injection COMBINATION_PRODUCT

combined therapy

Favorable outcome; Unfavorable outcome

Percutaneous ethanol injection DRUG

Percutaneous ethanol injection of HCC

Also known as: ETHANOL

Favorable outcome; Unfavorable outcome

Systemic chemotherapy DRUG

Systemic chemotherapy

Also known as: MIXED

Unfavorable outcome

Sorafenib DRUG

Sorafenib

Also known as: NEXAVAR

Unfavorable outcome

Viscum DIETARY_SUPPLEMENT

Viscum for HCC

Unfavorable outcome

Symptomatic treatment DRUG

Symptomatic treatment

Also known as: SUPPORTIVE

Unfavorable outcome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult patients
• with hepatocellular carcinoma

You may not qualify if:

• severely-ill patients
• With other system comorbidities,
• presence of extrahepatic metastasis,
• patients who dropped from the follow-up list after treatment.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation; Hepatectomy; Ethanol; Neoadjuvant Therapy; Sorafenib; Palliative Care

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Digestive System Surgical Procedures; Alcohols; Organic Chemicals; Combined Modality Therapy; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emad A. Ahmed, MD, PhD

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 17, 2020
• Study Start: June 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09