Studies immune checkpoint drugs in patients with liver cancer

Trial details

Who runs it

Ain Shams University

Trial code

NCT07088081

Record updated

28 July 2025

Original description

This study aims to evaluate the response to immunotherapy in HCC, assess the toxicity profile and measure overall survival within the study period. The primary end point is evaluation of progression free survival in HCC patients receiving immunotherapy. The secondary end point is to assess overall survival within the study period, duration of response and the response rate. The tertiary end point is to assess the toxicity profile.Read full original descriptionShow less

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

This study aims to evaluate the response to immunotherapy in HCC, assess the toxicity profile and measure overall survival within the study period. The primary end point is evaluation of progression free survival in HCC patients receiving immunotherapy. The secondary end point is to assess overall survival within the study period, duration of response and the response rate. The tertiary end point is to assess the toxicity profile.

Inclusion: 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.

Exclusion: 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; 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; 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; 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.

ClinicalTrials.gov NCT07088081