Evaluation of Efficacy and Safety of Immune Check Point Inhibitors in Hepatocellular Carcinoma Patients in Ain Shams University Hospitals

Prior treatment

• HCV or HBV infection except if; HBV DNA \< 500 IU/ml or started anti- HBV treatment for a minimum of 14 days prior to first dose
• Severe infection requiring hospitalization within 4 weeks prior to first dose
• Treatment with systemic immunostimulatory or immunosuppressive medication
• Receiving a live, attenuated vaccine within 4 weeks prior to first dose
• Prior history of hypertensive crisis or hypertensive encephalopathy

Other illness

• Active tuberculosis or active human immunodeficiency virus (HIV) infection
• History of allogenic stem cell or solid organ transplant
• Active and history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, or evidence of active pneumonitis
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• Cardiac conditions, such as severe heart failure, unstable angina, recent myocardial infarction, severe arrhythmias
• Evidence of bleeding diathesis or coagulopathy Special for atezolizumab + bevacizumab
• Main portal vein tumor thrombosis

Lab values

• Symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/1 (6 mg/dl), calcium \> 12 mg/dl, or corrected serum calcium \> ULN)
• Severe portal hypertensive gastropathy which is associated with decline in hemoglobin, uniess controlled

Other

• Performance status ≥ 2
• Patients with Child-Pugh class B or C
• BCLC stage A or D
• Central nervous system metastases
• Risky esophageal or gastric varies unless adequately managed
• Severe proteinuria ≥ 3.5 g/24 hrs or by dipstick 4+ proteinuria, according to CTCAE. Special for tremelimumab + durvalumab

• Age ≥ 18.
• Hepatocellular carcinoma based on histological diagnosis or the typical findings on radiological imaging including enhanced dynamic computed tomography (CT) and/or dynamic magnetic resonance imaging (MRI).
• ECOG Performance status of 0 or 1
• Patients with Child-Pugh class A
• BCLC stage B with diffuse, infiltrative, or extensive bilobar involvement
• BCLC stage B with tumor progression after failure of TACE
• BCLC stage C
• No prior systemic therapy for HCC
• Additional eligibility criteria; Hb ≥ 9 g/dl, platelets ≥ 75x10%/1, ANC ≥ 1.5 x10% for Atezolizumab/bevacizumab and ANC ≥ 1x10%1 for Durvalumab/Tremilimumab, INR ≤ 2, albumin ≥ 2.8 g/dl, total bilirubin
  • ≤ 3 mg/dl, AST and ALT ≤ 5 x ULN, creatinine clearance ≥ 50 ml/min
• Additional criteria for Atezolizumab/Bevacizumab; upper endoscopy showing no risky high grade esophageal varices (within 6 months of first dose) unless adequately managed