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

Ki vehet részt

• 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

Ki nem vehet részt

• 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)