NCT07904494Not yet recruiting

Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma

Association Between Immune-Related Adverse Events and Therapeutic Efficacy of First-Line Immunotherapy in Unresectable Hepatocellular Carcinoma Patients

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

The goal of this observational study is to evaluate how well first-line immunotherapy works and investigate its association with immune-related adverse events (irAEs) in Egyptian adults with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The main questions this study aims to answer are: * Are immune-related adverse events (irAEs), which are side effects caused by activation of the immune system, associated with treatment response and survival? * How effective and safe is first-line immunotherapy in Egyptian patients with unresectable HCC? The study will also explore whether routine blood markers, including eosinophil counts and markers of inflammation and nutritional status, are associated with treatment outcomes and the development of immune-related side effects. Changes in liver function and patients' health-related quality of life will also be evaluated. Approximately 294 patients receiving first-line immunotherapy as part of their routine medical care will be included. Patients may receive atezolizumab plus bevacizumab or durvalumab plus tremelimumab, as prescribed by their treating physicians. Researchers will not assign treatments or change patients' medical care. The study will include a review of existing medical records and prospective follow-up of eligible patients. Researchers will: * Review medical records to collect information about treatment, routine blood tests, imaging results, side effects, and clinical outcomes. * Follow eligible patients during routine medical visits to assess treatment response, survival, adverse events, and changes in liver function. * Ask prospectively enrolled participants to complete questionnaires about their health-related quality of life during scheduled follow-up assessments. Researchers will compare treatment outcomes between patients who develop irAEs and those who do not, while taking into account when these side effects occur.

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 294 (estimated)
First submitted: 18 Oct 2026
Start date: 1 Nov 2026
Primary completion date: 1 Oct 2027
Lead sponsor: Assiut University
Diseases: Liver and biliary tract cancer
NCT number: NCT07904494

What you commit to

Study type: Observational
Planned participants: 294
From 1 Nov 2026 to the primary completion date, 1 Oct 2027
4 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Systemic therapy history: History of prior systemic anticancer therapy for hepatocellular carcinoma, including but not limited to tyrosine kinase inhibitors, chemotherapy, monoclonal antibodies, or immune checkpoint inhibitors, anti V-EGF.
Mixed hepatocellular-cholangiocarcinoma or the presence of an additional primary malignancy requiring concurrent treatment.

Other illness

Autoimmune conditions: Active, severe autoimmune diseases requiring systemic immunosuppressive therapy.
Tumor histology and malignancy:

Lab values

Missing essential baseline, laboratory, imaging, or survival data.

Other

Liver function: Advanced liver decompensation is defined as any of the following Child-Pugh Class B8-9 or C, refractory ascites, or active hepatic encephalopathy.
Performance status: Poor Performance Status (ECOG score \> 2)

Who the study is looking for

Age: Adult patients (≥ 18 years)
Diagnosis: Patients with histologically or radiologically confirmed uHCC, according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD).
Disease stage: Unresectable, locally advanced, or metastatic disease, Barcelona Clinic Liver Cancer (BCLC) B or C.
Systemic therapy eligibility: Eligible to receive first-line systemic immunotherapy-based combination regimens, as per institutional protocol at the time of treatment initiation, including:
- Atezolizumab plus Bevacizumab
- Durvalumab plus Tremelimumab
- Other approved standard-of-care combinations adopted during the study period
Performance status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Liver function: Child-Pugh Class A or B (specifically Class A, 5-6 points, or Class B7, 7 points, only).
Measurable disease: At least one measurable lesion on baseline radiological imaging, assessable according to RECIST version 1.1 or modified RECIST (mRECIST) criteria.
Systemic therapy history: No prior systemic treatment for advanced or metastatic HCC. Prior locoregional therapy (e.g., TACE, HAIC, SBRT, ablation) is permitted if completed more than 4 weeks before immunotherapy initiation.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
El-Mabaraa Health Insurance Hospital Coordinator of this site? Confirm its status	Asyut	Egypt	Unknown status
Al-Rajhi University Hospital, Assiut University Coordinator of this site? Confirm its status	Asyut	Egypt	Unknown status
National Liver Institute, Menoufia University Coordinator of this site? Confirm its status	Shibīn al Kawm	Egypt	Unknown status
Menoufia Cancer Institute, Menoufia University Coordinator of this site? Confirm its status	Shibīn al Kawm	Egypt	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.