Trans-arterial Chemoembolization in Patients With Hepatocellular Carcinoma: A Study of Different Outcomes and Their Predictive Factors
1 other identifier
observational
100
1 country
1
Brief Summary
Radiological response after trans arterial chemoembolization (TACE) is classified according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) to: complete response (CR) (disappearance of arterial enhancement), partial response (PR) ( at least a 30% decrease in the sum of diameters of viable enhancement), progressive disease (PD) (an increase of at least 20% in the sum of the diameters of viable enhancement, or appearance of new lesions), and stable disease (any cases that do not qualify for either partial response or progressive disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedFebruary 4, 2021
February 1, 2021
1.1 years
March 25, 2020
February 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Post_TACE hepatic cell failure
Frequency of liver cell failure in form of jaundice , coagulopathy and encephalopathy
1 year
Study Arms (1)
TACE in HCC group 1
the patient did undergo tace
Interventions
Trans-arterial chemoembolization in patients with hepatocellular carcinoma
Eligibility Criteria
Patients with HCC with TACE
You may qualify if:
- Clinical history and examination with special stress on symptoms and signs of chronic liver disease with or without evidence of hepatic decompensation e.g. the presence of ascites and with or without evidence of complications e.g. jaundice spider naevi, bleeding varices, ascites, and lower limb edema.
- Laboratory findings in the form of raised bilirubin and liver enzymes, impaired coagulation profile, and/or low serum albumin.
- Abdominal ultrasonography revealing liver cirrhosis (coarse echopattern, attenuated hepatic veins, irregular outlines, hypertrophy of caudate lobe and/or shrunken liver, presence of focal hepatic) and presence of splenomegaly, ascites, or portal vein thrombosis (PVT).
You may not qualify if:
- A patient who had surgical resection or liver transplantation Patients refuse to participate Hepatic focal lesion other than HCC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut
Asyut, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 35 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident of tropical medicine
Study Record Dates
First Submitted
March 25, 2020
First Posted
February 4, 2021
Study Start
December 1, 2020
Primary Completion
December 30, 2021
Study Completion
March 30, 2022
Last Updated
February 4, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share