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Hepatocellular CarcinomaNCT07904494

Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma

An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma (HCC), run by Assiut University at 4 sites in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to evaluate how well first-line immunotherapy works and investigate its association with immune-related adverse events (irAEs) in Egyptian adults with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab plus bevacizumab and Durvalumab Plus Tremelimumab
Type of treatment
Injection or infusion
How many people
294 participants
Where
4 sitesEgypt
Study dates
1 Nov 2026to 1 Nov 2027
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: The study population will include Egyptian adults (≥18 years) with unresectable hepatocellular carcinoma (BCLC stage B or C) receiving first-line immune checkpoint inhibitor-based combination therapy in routine clinical practice. Eligible regimens currently include atezolizumab plus bevacizumab and durvalumab plus tremelimumab (STRIDE). Other approved standard-of-care ICI-based combinations adopted during the study period may also be included, in accordance with the approved protocol. Patients will be identified at Al-Rajhi University Hospital (Assiut University), El-Mabaraa Health Insurance Hospital (Assiut), Menoufia Cancer Institute and the National Liver Institute (Menoufia University). Both retrospectively identified and prospectively enrolled patients meeting the eligibility criteria will be included.

Who may be able to join

  • Age: Adult patients (≥ 18 years)
  • Diagnosis: Patients with histologically or radiologically confirmed uHCC, according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD).
  • Disease stage: Unresectable, locally advanced, or metastatic disease, Barcelona Clinic Liver Cancer (BCLC) B or C.
  • Systemic therapy eligibility: Eligible to receive first-line systemic immunotherapy-based combination regimens, as per institutional protocol at the time of treatment initiation, including:
  • Atezolizumab plus Bevacizumab
  • Durvalumab plus Tremelimumab
Show all 11Show fewer
  • Other approved standard-of-care combinations adopted during the study period
  • Performance status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
  • Liver function: Child-Pugh Class A or B (specifically Class A, 5-6 points, or Class B7, 7 points, only).
  • Measurable disease: At least one measurable lesion on baseline radiological imaging, assessable according to RECIST version 1.1 or modified RECIST (mRECIST) criteria.
  • Systemic therapy history: No prior systemic treatment for advanced or metastatic HCC. Prior locoregional therapy (e.g., TACE, HAIC, SBRT, ablation) is permitted if completed more than 4 weeks before immunotherapy initiation.

Who cannot join

  • Systemic therapy history: History of prior systemic anticancer therapy for hepatocellular carcinoma, including but not limited to tyrosine kinase inhibitors, chemotherapy, monoclonal antibodies, or immune checkpoint inhibitors, anti V-EGF.
  • Liver function: Advanced liver decompensation is defined as any of the following Child-Pugh Class B8-9 or C, refractory ascites, or active hepatic encephalopathy.
  • Performance status: Poor Performance Status (ECOG score > 2)
  • Autoimmune conditions: Active, severe autoimmune diseases requiring systemic immunosuppressive therapy.
  • Tumor histology and malignancy:
  • Mixed hepatocellular-cholangiocarcinoma or the presence of an additional primary malignancy requiring concurrent treatment.
  • Missing essential baseline, laboratory, imaging, or survival data.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Norhan Attia Ahmed, M.Sc. in Clinical Pharmacy contact

+201229824646

norhan_attia@pharm.aun.edu.eg

Mohamed Mahmoud Abdel-Latif, Ph.D. in Clinical Pharmacy contact

+201010607375

m.abdellatif@aun.edu.eg

Egypt4 sites

  • El-Mabaraa Health Insurance Hospital

    Asyut, Asyut Governorate, 71511

    Norhan A Ahmed, M.SC. in Clinical Pharmacy, +201229824646, norhan_attia@pharm.aun.edu.eg

  • Al-Rajhi University Hospital, Assiut University

    Asyut, Asyut Governorate, 71515

    Norhan A Ahmed, M.SC. in Clinical Pharmacy, +201229824646, norhan_attia@pharm.aun.edu.eg

  • Menoufia Cancer Institute, Menoufia University

    Shibīn al Kawm, Menoufia, 32511

    Norhan A Ahmed, M.SC. in Clinical Pharmacy, +201229824646, norhan_attia@pharm.aun.edu.eg

  • National Liver Institute, Menoufia University

    Shibīn al Kawm, Menoufia, 32511

    Norhan A Ahmed, M.SC. in Clinical Pharmacy, +201229824646, norhan_attia@pharm.aun.edu.eg

Other trials in Egypt

About this study

Official title: Association Between Immune-Related Adverse Events and Therapeutic Efficacy of First-Line Immunotherapy in Unresectable Hepatocellular Carcinoma Patients

The goal of this observational study is to evaluate how well first-line immunotherapy works and investigate its association with immune-related adverse events (irAEs) in Egyptian adults with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery.

The main questions this study aims to answer are:

Read more
  • Are immune-related adverse events (irAEs), which are side effects caused by activation of the immune system, associated with treatment response and survival?
  • How effective and safe is first-line immunotherapy in Egyptian patients with unresectable HCC?

The study will also explore whether routine blood markers, including eosinophil counts and markers of inflammation and nutritional status, are associated with treatment outcomes and the development of immune-related side effects. Changes in liver function and patients' health-related quality of life will also be evaluated.

Approximately 294 patients receiving first-line immunotherapy as part of their routine medical care will be included. Patients may receive atezolizumab plus bevacizumab or durvalumab plus tremelimumab, as prescribed by their treating physicians. Researchers will not assign treatments or change patients' medical care.

The study will include a review of existing medical records and prospective follow-up of eligible patients. Researchers will:

  • Review medical records to collect information about treatment, routine blood tests, imaging results, side effects, and clinical outcomes.
  • Follow eligible patients during routine medical visits to assess treatment response, survival, adverse events, and changes in liver function.
  • Ask prospectively enrolled participants to complete questionnaires about their health-related quality of life during scheduled follow-up assessments.

Researchers will compare treatment outcomes between patients who develop irAEs and those who do not, while taking into account when these side effects occur.

Read the detailed description

This multicenter, ambispective (retrospective and prospective) observational cohort study aims to evaluate the therapeutic efficacy of first-line immunotherapy and investigate its association with immune-related adverse events (irAEs) in Egyptian patients with unresectable hepatocellular carcinoma (uHCC).

The study will be conducted at four specialized healthcare institutions in Egypt: Al-Rajhi University Hospital, Assiut University; El-Mabaraa Health Insurance Hospital, Assiut; Menoufia Cancer Institute; and the National Liver Institute, Menoufia University.

The study population consists of adult patients with uHCC receiving first-line immune checkpoint inhibitor-based therapy (such as atezolizumab plus bevacizumab or durvalumab plus tremelimumab) in routine clinical practice. Treatment decisions and clinical management remain entirely at the discretion of the treating physicians, without any investigator-directed treatment allocation.

The retrospective component will extract baseline clinical characteristics, treatment exposure, adverse events, laboratory findings, radiological assessments, and available clinical outcomes from the medical records of eligible patients who initiated immunotherapy before study commencement. Newly eligible patients will be enrolled and followed prospectively.

A primary focus of the study is to evaluate treatment safety through the continuous documentation of irAEs, emphasizing their occurrence, type, timing, severity (using CTCAE v5.0), and management. Crucially, the association between irAEs and therapeutic efficacy will be investigated using appropriate statistical methods that account for the timing of irAE onset, including time-dependent survival analyses to minimize immortal time bias.

An exploratory comparative analysis will be conducted between patients receiving first-line atezolizumab plus bevacizumab and those receiving durvalumab plus tremelimumab (STRIDE). Comparisons will include therapeutic efficacy, assessed by overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as treatment safety, including the incidence and severity of immune-related and non-immune-related adverse events. Differences in liver function, inflammatory and immunonutritional biomarkers, and health-related quality of life may also be explored where sufficient data are available. Relevant baseline clinical differences between treatment groups will be considered using appropriate statistical adjustment methods when feasible.

Beyond irAEs, exploratory analyses will investigate the potential prognostic and predictive roles of peripheral blood eosinophil counts and selected systemic inflammatory and immunonutritional markers. These include the absolute eosinophil count (AEC), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), and prognostic nutritional index (PNI). Longitudinal changes in these markers, alongside hepatic function assessments (Child-Pugh and ALBI scores), will be evaluated to explore factors associated with hepatic deterioration and treatment outcomes.

Health-related quality of life (HRQoL) will be assessed among prospectively enrolled patients using the Arabic versions of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the hepatocellular carcinoma-specific module (EORTC QLQ-HCC18). Assessments are planned at baseline and every three months during follow-up, with additional assessments at disease progression or treatment discontinuation when feasible. Longitudinal changes in global health status, functional domains, and symptom scores will be evaluated. Clinically meaningful deterioration in HRQoL may also be explored when sufficient follow-up data are available.

Statistical analyses will utilize regression models and survival analysis (Kaplan-Meier and Cox proportional hazards models). As an observational study, research activities at each participating center will be conducted strictly in accordance with applicable ethical approvals and institutional guidelines, without modifying routine clinical care.

Being tested
Atezolizumab plus bevacizumab, Durvalumab Plus Tremelimumab
Keywords
Immunotherapy, Immune-Related adverse events, Immune Checkpoint Inhibitors, Unresectable Hepatocellular Carcinoma, Therapeutic Efficacy, Atezolizumab, Durvalumab, biomarkers
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab plus bevacizumabDrug

    Also called Tecentriq, Avastin, Atez/Bev

    Patients receive atezolizumab (1,200 mg intravenously) plus bevacizumab (15 mg/kg intravenously) every 3 weeks as first-line treatment for unresectable hepatocellular carcinoma, according to routine clinical practice. Treatment selection, administration, and modifications are determined by the treating physician and are not assigned by the study investigators.

  • Durvalumab Plus TremelimumabDrug

    Also called STRIDE, Imfinzi, Imjudo

    Patients receive a single intravenous dose of tremelimumab (300 mg) combined with durvalumab (1,500 mg) on day 1, followed by durvalumab (1,500 mg intravenously) every 4 weeks, according to routine clinical practice. Treatment selection, administration, and modifications are determined by the treating physician and are not assigned by the study investigators.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Odds Ratio for Objective Tumor Response According to Immune-Related Adverse Event Status (RECIST 1.1)

    The odds ratio (OR) of objective tumor response in patients with versus without immune-related adverse events (irAEs) will be estimated, with 95% confidence intervals. Objective response is defined as a best overall response of complete response (CR) or partial response (PR), assessed by CT or MRI according to RECIST version 1.1. irAEs will be identified through clinical assessment and medical record review, with their dates of onset documented. The timing of irAE occurrence will be considered in the prespecified association analysis to minimize time-related bias. The reported association measurث will be an odds ratio (unitless).

    Measured: From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months.

  2. Hazard Ratio for Overall Survival According to Time-Varying Immune-Related Adverse Event Status

    The hazard ratio (HR) for all-cause mortality associated with immune-related adverse event (irAE) occurrence will be estimated using time-dependent Cox proportional hazards regression, with 95% confidence intervals. Overall survival (OS) is defined as the time from the first dose of immunotherapy to death from any cause, measured in months. Patients alive at the last known follow-up will be censored. irAEs will be identified through clinical assessment and medical record review, with their dates of onset documented. irAE status will be modeled as a time-varying exposure, classified as unexposed before the first irAE onset and exposed thereafter. The reported association measure will be a hazard ratio (unitless)

    Measured: From the first dose of immunotherapy until death from any cause or last known follow-up, assessed up to 12 months.

Secondary outcomes (16)

  1. Percentage of Patients Experiencing at Least One Immune-Related Adverse Event (irAE)

    The percentage of patients experiencing at least one immune-related adverse event (irAE) following initiation of first-line immunotherapy will be determined. irAEs will be identified through clinical assessment and medical record review, including available laboratory and radiological findings, after consideration of alternative causes. Events will be classified and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Each patient will be counted once regardless of the number of irAEs experienced. The outcome will be reported as the percentage of patients with at least one irAE.

    Measured: From the first dose of immunotherapy until death or last available safety assessment, assessed up to 12 months.

  2. Percentage of Patients Experiencing Grade 3 or Higher Immune-Related Adverse Events

    The percentage of patients experiencing at least one severe immune-related adverse event (irAE), defined as Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, will be determined. Severity will be assessed using the maximum documented CTCAE grade for each irAE. Each patient will be counted once if at least one Grade 3 or higher irAE occurs. The outcome will be reported as the percentage of patients with Grade 3 or higher irAEs.

    Measured: From the first dose of immunotherapy until death or the last available safety assessment, assessed up to 12 months.

  3. Hazard Ratio for Progression-Free Survival According to Time-Varying Immune-Related Adverse Event Status

    The hazard ratio (HR) for disease progression or death associated with immune-related adverse event (irAE) occurrence will be estimated using time-dependent Cox proportional hazards regression, with 95% confidence intervals. Progression-free survival (PFS) is defined as the time in months from the first dose of immunotherapy to the first documented radiological disease progression or death from any cause, whichever occurs first. Radiological progression will be assessed using CT or MRI according to RECIST version 1.1 in patients with adequate evaluable imaging. Patients without documented progression or death will be censored at their last adequate tumor assessment. irAE status will be modeled as a time-varying exposure based on the date of first irAE onset. The reported association measure will be a hazard ratio (unitless).

    Measured: From the first dose of immunotherapy until first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.

  4. Odds Ratio for Disease Control According to Immune-Related Adverse Event Status (RECIST 1.1)

    The odds ratio (OR) for achieving disease control in patients with versus without immune-related adverse events (irAEs) will be estimated, with 95% confidence intervals. Disease control is defined as a best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by CT or MRI according to RECIST version 1.1. irAEs will be identified through clinical assessment and medical record review, with their dates of onset documented. The timing of irAE occurrence will be considered in the prespecified association analysis to minimize time-related bias. The reported association measure will be an odds ratio (unitless).

    Measured: From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months.

  5. Percentage of Patients Experiencing at Least One Non-Immune-Related Adverse Event

    The percentage of patients experiencing at least one non-immune-related adverse event following initiation of first-line immunotherapy-based treatment will be determined. Events will be identified through clinical assessment and medical record review and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Events may include hypertension, bleeding, and thromboembolic complications when classified as non-immune-related. Each patient will be counted once regardless of the number of qualifying events. The outcome will be reported as the percentage of patients (%).

    Measured: From the first dose of immunotherapy until death or last available safety assessment, assessed up to 12 months.

  6. Change From Baseline in Albumin-Bilirubin (ALBI) Score During Immunotherapy

    Changes in liver function will be assessed using the albumin-bilirubin (ALBI) score, calculated from serum albumin and total bilirubin concentrations. ALBI score will be calculated as (0.66 × log10 total bilirubin [µmol/L]) - (0.085 × serum albumin [g/L]). Change from baseline will be calculated as the ALBI score at each available follow-up assessment minus the baseline ALBI score. Higher ALBI scores indicate worse liver function. Results will be reported as changes in the unitless ALBI score.

    Measured: At baseline and during each treatment cycle until disease progression, death, or last available liver function assessment, assessed up to 12 months.

  7. Change From Baseline in Child-Pugh Score During Immunotherapy

    Changes in hepatic functional status will be assessed using the Child-Pugh score, based on serum bilirubin, serum albumin, international normalized ratio (INR), ascites, and hepatic encephalopathy. The total score ranges from 5 to 15 points, with higher scores indicating worse liver function. Change from baseline will be calculated as the Child-Pugh score at each evaluable follow-up assessment minus the baseline score. Results will be reported in Child-Pugh score points.

    Measured: At baseline and each available treatment cycle until disease progression, death, or the last available liver function assessment, up to 12 months.

  8. Change From Baseline in EORTC QLQ-C30 Summary Score

    The EORTC QLQ-C30 Summary Score will be calculated using the validated Arabic questionnaire. It combines 13 scales: five functional scales, three multi-item symptom scales, and five single-item symptom scales. Symptom scores will be reversed, and the mean of the 13 scales will be calculated according to EORTC scoring guidelines. The score ranges from 0 to 100, with higher scores indicating better overall quality of life. Change from baseline will be reported in points.

    Measured: At baseline and every 3 months during follow-up, with additional assessment at disease progression or treatment discontinuation when feasible, up to 12 months.

  9. Change From Baseline in EORTC QLQ-HCC18 Index Score

    HCC-specific quality of life will be assessed using the validated Arabic EORTC QLQ-HCC18 questionnaire. It includes six multi-item scales (fatigue, jaundice, body image, nutrition, pain, and fever) and two single items (sexual interest and abdominal swelling). Each scale will be transformed to 0-100 according to EORTC scoring guidelines. The HCC18 Index Score is the mean of the eight scale scores, ranging from 0 to 100. Higher scores indicate greater symptom burden and worse quality of life. Change from baseline will be reported in points.

    Measured: At baseline and every 3 months during follow-up, with additional assessment at disease progression or treatment discontinuation when feasible, up to 12 months.

  10. Change From Baseline in Absolute Eosinophil Count (AEC) During Immunotherapy

    Longitudinal changes in peripheral blood absolute eosinophil count (AEC) will be assessed using complete blood count with differential leukocyte count. AEC will be recorded in cells/µL at baseline and at available follow-up assessments. Change from baseline will be calculated as the follow-up AEC minus the baseline AEC. Results will be reported in cells/µL.

    Measured: At baseline and during available treatment cycles (approximately every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or the last available laboratory assessment, up to 12 months.

  11. Exploratory Real-World Comparison of Effectiveness and Safety Between First-Line Immunotherapy Regimens in Egypt

    An exploratory comparison between atezolizumab plus bevacizumab and tremelimumab plus durvalumab (STRIDE) will be performed among Egyptian patients with unresectable hepatocellular carcinoma receiving first-line immunotherapy in routine clinical practice. Clinical outcomes will include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and the incidence and severity of adverse events. Baseline clinical differences between treatment groups will be considered in adjusted comparative analyses where feasible

    Measured: From the first dose of immunotherapy until the applicable outcome event or last available assessment, including death for OS and disease progression or death for PFS, assessed up to 12 months.

  12. Change From Baseline in Prognostic Nutritional Index (PNI) During Immunotherapy

    Longitudinal changes in the prognostic nutritional index (PNI) will be evaluated using serum albumin concentrations and absolute lymphocyte counts obtained from routine laboratory assessments. PNI will be calculated as [10 × serum albumin (g/dL)] + [0.005 × absolute lymphocyte count (cells/µL)]. Change from baseline will be calculated as the follow-up PNI minus the baseline PNI. Higher PNI values generally indicate better nutritional and immunological status. Results will be reported as changes in PNI index points.

    Measured: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.

  13. Change From Baseline in Neutrophil-to-Lymphocyte Ratio (NLR) During Immunotherapy

    Longitudinal changes in the neutrophil-to-lymphocyte ratio (NLR) will be evaluated using absolute neutrophil and lymphocyte counts obtained from routine complete blood count assessments. NLR will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count, with both counts expressed in the same units. Change from baseline will be calculated as the follow-up NLR minus the baseline NLR. Higher values indicate a greater relative neutrophil predominance. Results will be reported as changes in the unitless NLR.

    Measured: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.

  14. Change From Baseline in Platelet-to-Lymphocyte Ratio (PLR) During Immunotherapy

    Longitudinal changes in the platelet-to-lymphocyte ratio (PLR) will be evaluated using platelet and absolute lymphocyte counts obtained from routine complete blood count assessments. PLR will be calculated by dividing the platelet count by the absolute lymphocyte count, with both counts expressed in the same units. Change from baseline will be calculated as the follow-up PLR minus the baseline PLR. Higher values indicate greater platelet predominance relative to lymphocytes. Results will be reported as changes in the unitless PLR.

    Measured: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.

  15. Change From Baseline in Systemic Immune-Inflammation Index (SII) During Immunotherapy

    Longitudinal changes in the systemic immune-inflammation index (SII) will be evaluated using platelet, absolute neutrophil, and absolute lymphocyte counts obtained from routine complete blood count assessments. SII will be calculated as [platelet count × absolute neutrophil count] / absolute lymphocyte count, with all counts expressed in 10⁹/L. Change from baseline will be calculated as the follow-up SII minus the baseline SII. Higher values indicate greater platelet-neutrophil predominance relative to lymphocytes. Results will be reported as changes in SII values (10⁹/L).

    Measured: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.

  16. Change From Baseline in Systemic Inflammation Response Index (SIRI) During Immunotherapy

    Longitudinal changes in the systemic inflammation response index (SIRI) will be evaluated using absolute neutrophil, monocyte, and lymphocyte counts obtained from routine complete blood count assessments. SIRI will be calculated as [absolute neutrophil count × absolute monocyte count] / absolute lymphocyte count, with all counts expressed in 10⁹/L. Change from baseline will be calculated as the follow-up SIRI minus the baseline SIRI. Higher values indicate greater neutrophil-monocyte predominance relative to lymphocytes. Results will be reported as changes in SIRI values (10⁹/L).

    Measured: At baseline and during each treatment cycle (every 3 weeks for atezolizumab plus bevacizumab and every 4 weeks for STRIDE), until disease progression, death, or last available laboratory assessment, assessed up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

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
Other
Enrolment
294 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904494
Sponsor's protocol ID
irAE-Efficacy-HCC-Egypt
Status last verified
Oct 2026
First submitted
18 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is currently no plan to share individual participant-level data outside the study team. The study involves sensitive clinical data collected across multiple institutions, and any future data sharing would require appropriate ethical and institutional approvals and data protection safeguards. Study findings will be disseminated in aggregate form through scientific publications and presentations.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma (HCC), run by Assiut University at 4 sites 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 7 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Contact Norhan Attia Ahmed, M.Sc. in Clinical Pharmacy (+201229824646, norhan_attia@pharm.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds Ratio for Objective Tumor Response According to Immune-Related Adverse Event Status (RECIST 1.1) (time frame: From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07904494.

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 29 Oct 2026.

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