An observational study in HCC - Hepatocellular Carcinoma, Immunotherapy and Immune Checkpoint Therapy, sponsored by Ain Shams University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Ain Shams University · Observational
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.
Treatment starts after MDT discussion and approval for diagnosis, staging and treatment protocol.
Baseline investigations will include;
Laboratory ;
t) Others; HBAlc, Thyroid function tests (TSH, T3, T4), Alpha feto protein
Radiological imagings;
3,183 studies on the registry are indexed under Carcinoma, Hepatocellular; 955 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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
Exclusion Criteria:
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
Time frame: 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
overall survival within the study period,
Overall survival (OS) is defined as time from diagnosis to either last follow-up or /death
Time frame: 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
Response rate is defined as the proportion of patients with a complete response/immune complete response or partial response/ immune partial response to treatment
Time frame: From enrollment to study till 1 year or treatment
Assess the toxicity profile of immunotherapy
The degree of adverse events was evaluated according to The Common Terminology Criteria for Adverse Events version 5.0. ,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.
Time frame: From enrollment to 1 year of treatment
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University