HCC - Hepatocellular CarcinomaNCT07088081
Evaluation of Efficacy and Safety of Immune Check Point Inhibitors in Hepatocellular Carcinoma Patients in Ain Shams University Hospitals
An observational study of HCC - Hepatocellular Carcinoma and Immunotherapy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Immunotherapy, Immune Checkpoint Therapy
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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;
- Laboratory ;
- CBC
- liver enzymes (ALT, AST, alkaline phosphatase, GGT)
- liver function tests (serum albumin, serum bilirubin total and direct, INR)
- kidney function tests (serum creatinine, BUN, 24 hrs urinary protein)
- electrolytes Na, K, Ca)
- Others; HBAlc, Thyroid function tests (TSH, T3, T4), Alpha feto protein
- Radiological imagings;
- Triphasic CT and/or dynamic MRI abdomen
- PET scan or CT chest and bone scan
- 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
- Keywords
- Immune check points inhibitors efficacy, Immune check points inhibitors safety, Response evaluation in hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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,
Overall survival (OS) is defined as time from diagnosis to either last follow-up or /death
Measured: 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
Measured: From enrollment to study till 1 year or treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088081
- Sponsor's protocol ID
- FMASU MD111/2025
- Status last verified
- Jun 2025
- First submitted
- 5 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Immune Check Point Inhibitors in Hepatocellular Carcinoma Patients in Ain Shams University Hospitals
- ClinicalTrials.gov ID
- NCT07088081
- Acronym / sponsor ID
- FMASU MD111/2025
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Laboratory ;
- CBC
- liver enzymes (ALT, AST, alkaline phosphatase, GGT)
- liver function tests (serum albumin, serum bilirubin total and direct, INR)
- kidney function tests (serum creatinine, BUN, 24 hrs urinary protein)
- electrolytes Na, K, Ca)
- Others; HBAlc, Thyroid function tests (TSH, T3, T4), Alpha feto protein
- Radiological imagings;
- Triphasic CT and/or dynamic MRI abdomen
- PET scan or CT chest and bone scan
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival in HCC patients receiving immunotherapy.
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
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
2 secondary outcomes
overall survival within the study period,
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
Time frame: From enrollment to study till 1 year or treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and Immunotherapy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival in HCC patients receiving immunotherapy. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.