Evaluation of Efficacy and Safety of Immune Check Point Inhibitors in Hepatocellular Carcinoma Pa… (NCT07088081) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of Efficacy and Safety of Immune Check Point Inhibitors in Hepatocellular Carcinoma Patients in Ain Shams University Hospitals
Egypt30 participantsStarted 2025-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Performance status ≥ 2
* Patients with Child-Pugh class B or C
* BCLC stage A or D
* Active tuberculosis or active human immunodeficiency virus (HIV) infection
* 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
* History of allogenic stem cell or solid organ transplant
* Treatment with systemic immunostimulatory or immunosuppressive medication
* Active and history of…
What they're measuring
1
Progression free survival in HCC patients receiving immunotherapy.
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months