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NCT07904494

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

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

294

Start Date

2026-11-01

Completion Date

2027-11-01

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Hepatocellular Carcinoma Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma Non-Resectable Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma of the Liver Liver Cancer Liver Cancer (Primary and Metastatic)Liver Neoplasms

Interventions

DRUG

Atezolizumab plus bevacizumab

Patients receive atezolizumab (1,200 mg intravenously) plus bevacizumab (15 mg/kg intravenously) every 3 weeks as first-line treatment for unresectable hepatocellular carcinoma, according to routine clinical practice. Treatment selection, administration, and modifications are determined by the treating physician and are not assigned by the study investigators.

DRUG

Durvalumab Plus Tremelimumab

Patients receive a single intravenous dose of tremelimumab (300 mg) combined with durvalumab (1,500 mg) on day 1, followed by durvalumab (1,500 mg intravenously) every 4 weeks, according to routine clinical practice. Treatment selection, administration, and modifications are determined by the treating physician and are not assigned by the study investigators.

Inclusion Criteria: * 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 Criteria: * 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. * 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) * Autoimmune conditions: Active, severe autoimmune diseases requiring systemic immunosuppressive therapy. * Tumor histology and malignancy: * Mixed hepatocellular-cholangiocarcinoma or the presence of an additional primary malignancy requiring concurrent treatment. * Missing essential baseline, laboratory, imaging, or survival data.

Locations (4)

El-Mabaraa Health Insurance Hospital

Asyut, Asyut Governorate, Egypt

Al-Rajhi University Hospital, Assiut University

Asyut, Asyut Governorate, Egypt

Menoufia Cancer Institute, Menoufia University

Shibīn al Kawm, Menoufia, Egypt

National Liver Institute, Menoufia University