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

NCT ID: NCT07088081

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-07-31

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.

Detailed Description

Treatment starts after MDT discussion and approval for diagnosis, staging and treatment protocol.

• This study includes patients with advanced HCC who will receive their first line of treatment. Cases will receive atezolizumab (1200 mg) + bevacizumab (15mg/kg) every 3 weeks or Tremilimumab (300 mg single dose IV infusion on first day only) + Durvalumab (1500 mg on the same day then every 4 weeks) according to eligibility criteria.
• Cases will be evaluated every cycle clinically and laboratory.
• Baseline investigations will include;

1. Laboratory ;

1. CBC

2. liver enzymes (ALT, AST, alkaline phosphatase, GGT)

3. liver function tests (serum albumin, serum bilirubin total and direct, INR)

4. kidney function tests (serum creatinine, BUN, 24 hrs urinary protein)

5. electrolytes Na, K, Ca)

t) Others; HBAlc, Thyroid function tests (TSH, T3, T4), Alpha feto protein

2. Radiological imagings;

1. Triphasic CT and/or dynamic MRI abdomen

2. PET scan or CT chest and bone scan

3. ECG, ECHO, Upper GI endoscopy

• Every 3 months patients will undergo laboratory and radiological investigations, assessed by 2 blinded radiologists.
• The degree of adverse events was evaluated according to The Common Terminology Criteria for Adverse Events version 5.0.(30) ,which rates toxicity on a scale from 1 to 5, with ascending order of severity. This will be managed according to toxicity grade whether treatment interruption, dose reduction or discontinuation.
• Study treatment to be continued until disease progression, unacceptable toxicity, serious inter-current illness, patient request for discontinuation, or need for any other anticancer agent other than study treatment.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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 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
• Cardiac conditions, such as severe heart failure, unstable angina, recent myocardial infarction, severe arrhythmias
• Evidence of bleeding diathesis or coagulopathy Special for atezolizumab + bevacizumab
• Risky esophageal or gastric varies unless adequately managed
• Severe portal hypertensive gastropathy which is associated with decline in hemoglobin, uniess controlled
• Severe proteinuria ≥ 3.5 g/24 hrs or by dipstick 4+ proteinuria, according to CTCAE. Special for tremelimumab + durvalumab
• Main portal vein tumor thrombosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University

Cairo, Abbasya, Egypt

Countries

Egypt

Other Identifiers

FMASU MD111/2025

Identifier Type: -

Identifier Source: org_study_id