Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSohag University
About this trial
The goal of this observational study is to learn about the different treatment options for intermediate-stage hepatocellular carcinoma. The main question it aims to answer is:
\- What are the survival outcomes among participants aged 18 or older who receive treatment for intermediate-stage hepatocellular carcinoma?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years.
Both sexes.
Diagnosis of hepatocellular carcinoma based on accepted radiologic or histologic criteria.
Classified as intermediate stage (BCLC-B) at time of decision for first-line treatment.
Disqualifiers
BCLC A, C, or D at diagnosis.
Prior curative therapy (resection, transplantation, curative ablation).
Missing essential data (imaging, liver function, treatment records).
Mixed HCC-cholangiocarcinoma.
Trial population
Patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at Sohag Oncology Center.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Patients with intermediate-stage hepatocellular carcinoma (BCLC-B)
Trial outcomes
Primary outcomes
1
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death.
Time frame
From randomization to the end of treatment at 5 years.2
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death.
Time frame
From randomization to the end of treatment at 5 years.3
Objective response (mRECIST)
According to mRECIST for HCC, CR is the disappearance of any intratumoral arterial enhancement in all target lesions. PR is at least a 30% decrease in the sum of the diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of the target lesions. Overall response is a result of the combined assessment of target lesions, nontarget lesions and new lesions.
Time frame
From randomization to the end of treatment at 5 years.4
Adverse events (CTCAE)
An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. This definition is standardized by the Common Terminology Criteria for Adverse Events (CTCAE) system to ensure consistent reporting and grading of toxicity severity across studies.
Time frame
From randomization to the end of treatment at 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sohag University
Lead sponsor
Sohag Oncology Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: