Immune side effects and treatment results in adults with inoperable liver cancer
Looks at whether immune side effects relate to outcomes of first-line immunotherapy in liver cancer.
Plain-language title generated from the registry record
Registry title: Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Key facts
- Where
- Asyut and Shibīn al Kawm, EgyptSee the 4 sites
Where in Egypt
- Al-Rajhi University Hospital, Assiut UniversityAsyut, EgyptNo longer taking part
- El-Mabaraa Health Insurance HospitalAsyut, EgyptNo longer taking part
- Menoufia Cancer Institute, Menoufia UniversityShibīn al Kawm, EgyptNo longer taking part
- National Liver Institute, Menoufia UniversityShibīn al Kawm, EgyptNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assiut University
- Trial code
- NCT07904494
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
Association Between Immune-Related Adverse Events and Therapeutic Efficacy of First-Line Immunotherapy in Unresectable Hepatocellular Carcinoma Patients
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.
Inclusion: 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.
Exclusion: 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; Autoimmune conditions: Active, severe autoimmune diseases requiring systemic immunosuppressive therapy; Tumor histology and malignancy:; Missing essential baseline, laboratory, imaging, or survival data; 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).