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

NCT07088081 | Enrolling By Invitation DMC

• 1 other identifier: FMASU MD111/2025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCC - Hepatocellular Carcinoma; Immunotherapy; Immune Checkpoint Therapy; Immune Checkpoint Inhibitor-Induced Dermatitis; Atezolizumab and Bevacizumab in Hepatocellular Carcinoma; Durvalumab

Keywords

Immune check points inhibitors efficacy; Immune check points inhibitors safety; Response evaluation in hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival in HCC patients receiving immunotherapy.

  Progression-free survival (PFS) is defined as the time elapsed between treatment initiation and tumor progression or death from any cause. Progression (i.e., PD) was defined as presence of new measurable/non- measurable lesions, or ≥ 20% increase in tumour burden relative to nadir

  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

Secondary Outcomes (2)

• overall survival within the study period,

  From date of randomization until the date of loss of follow up or date of death from any cause, whichever came first, assessed up to 12 months

• Response rate

  From enrollment to study till 1 year or treatment

Other Outcomes (1)

• Assess the toxicity profile of immunotherapy

  From enrollment to 1 year of treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive sampling for patients fulfilling the eligibility criteria and after multidisciplinary team discussion at Clinical oncology department and HCC clinics, Ain Shams University Hospitals, Cairo.

You may qualify if:

• 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

You may not qualify if:

• 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 autoimmune disease or immune deficiency
• Receiving a live, attenuated vaccine within 4 weeks prior to first dose
• History of idiopathic pulmonary fibrosis, or evidence of active pneumonitis
• Central nervous system metastases
• Symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/1 (6 mg/dl), calcium \> 12 mg/dl, or corrected serum calcium \> ULN)
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• Prior history of hypertensive crisis or hypertensive encephalopathy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasya, 00202, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-06

Locations

EG (1)