Real-world Insight Into Systemic Therapies for HCC: Single-center Study

NCT07814014 | Recruiting

• 1 other identifier: MS.24.11.2985
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Real-world data from a single-center experience evaluating patients with hepatocellular carcinoma (HCC) receiving systemic therapies

Conditions

HCC - Hepatocellular Carcinoma

Keywords

HCC

Outcome Measures

Primary Outcomes (3)

• overall survival (OS)

  time from initiation of systemic therapy to death from any cause

  1 year

• 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

  1 year

• progression free survival (PFS)

  time from initiation of systemic therapy to radiological diseasas progression or death from any cause , whichever occur first

  one year

Secondary Outcomes (1)

• efficacy of DAAs in treatment of HCV in patients with active HCV infection and HCC during receiving systemic therapy

  1 year

Other Outcomes (1)

• Side effects

  1 year

Study Arms (1)

HCC patients on systemic therapies

1. HCC patients receiving TKI (Sorafenib and Regrofenib 2. HCC patients receiving Atezolizumab with Bevacizumab 3. HCC patients receiving Tremelimumab with Durvalumab 4 -HCC patients With positive PCR HCV treating by DAAs with systemic therapy

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

Mahmoud M El-Bendary, PhD

CONTACT

+201002592205; mmelbendary@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Tropical Hepatogastroenterology- Tropical Medicine department

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

EG (1)