Real-world Insight Into Systemic Therapies for HCC: Single-center Study
ConditionHCC - Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMansoura University
About this trial
Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patient with HCC
Child-Pugh class A, B7
Performance state 0-1 (Eastern Cooperative Oncology Group (ECOG scale).
Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B with diffuse, infiltrative or extensive bilobar involvement or BCLC stage B with tumor progression after TACE.
Disqualifiers
patient with other tumor than HCC
Child-Turcotte-Pugh score B (8,9) and C.
Patients eligible for treatment other than systemic therapy according to Barcelona Clinic liver cancer.
Trial population
Patients with HCC that are recruited to the tropical medicine inpatient department and outpatient clinics and are submitted to the inclusion and exclusion criteria from June 2022 to November 2024.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: HCC patients on systemic therapies
Trial outcomes
Primary outcomes
1
overall survival (OS)
time from initiation of systemic therapy to death from any cause
Time frame
1 year2
treatment response
m-RESIST analysis of the patients as its categories * CR - Complete response Disappearance of all arterial enhancement in all target lesions * PR - Partial response ≥30% decrease in the sum of diameters of viable tumor * SD - Stable disease Neither sufficient decrease for PR nor sufficient increase for PD * PD - Progressive disease ≥20% increase in the sum of viable tumor diameters, with an absolute increase of ≥5 mm, or appearance of new lesions/other progression criteria
Time frame
1 year3
progression free survival (PFS)
time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first
Time frame
one yearSecondary outcomes
1
efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy
treatment of HCV infection in patient with HCC and active HCV infection during receiving systemic therapy of HCC which will be assed by PCR done 12 w after the end of treatment , * SVR: HCV RNA remains undetectable 12 weeks after completing treatment. This is the standard definition of virologic cure. * Or non responder as HCV RNA is still detected after 12 w of complete treatment -how it will affect liver function
Time frame
1 yearOther outcomes
1
Side effects
adverse events related to systemic therapy of HCC
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov