NCT07088081

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: Egypt