Trial · NCT07904494
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
NCT07904494, Not yet recruiting, Assiut University
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma. Trials, record NCT07904494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
- NCT number
- NCT07904494
- Status
- Not yet recruiting
- Enrollment
- 294 participants, estimated
- Lead sponsor
- Assiut University
- Conditions
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Non-Resectable, Hepatocellular Carcinoma Metastatic, Hepatocellular Carcinoma of the Liver, Liver Cancer, Liver Cancer (Primary and Metastatic), Liver Neoplasms
- Interventions
- Atezolizumab plus bevacizumab, Durvalumab Plus Tremelimumab
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Odds Ratio for Objective Tumor Response According to Immune-Related Adverse Event Status (RECIST 1.1) | From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months. | 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). |
| Primary | Hazard Ratio for Overall Survival According to Time-Varying Immune-Related Adverse Event Status | From the first dose of immunotherapy until death from any cause or last known follow-up, assessed up to 12 months. | 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) |
| Secondary | Percentage of Patients Experiencing at Least One Immune-Related Adverse Event (irAE) | From the first dose of immunotherapy until death or last available safety assessment, assessed up to 12 months. | 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. |
| Secondary | Percentage of Patients Experiencing Grade 3 or Higher Immune-Related Adverse Events | From the first dose of immunotherapy until death or the last available safety assessment, assessed up to 12 months. | 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. |
| Secondary | Hazard Ratio for Progression-Free Survival According to Time-Varying Immune-Related Adverse Event Status | From the first dose of immunotherapy until first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months. | 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). |
| Secondary | Odds Ratio for Disease Control According to Immune-Related Adverse Event Status (RECIST 1.1) | From the first dose of immunotherapy until disease progression, death, or last evaluable tumor assessment, assessed up to 12 months. | 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). |
| Secondary | Percentage of Patients Experiencing at Least One Non-Immune-Related Adverse Event | From the first dose of immunotherapy until death or last available safety assessment, assessed up to 12 months. | 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 (%). |
| Secondary | Change From Baseline in Albumin-Bilirubin (ALBI) Score During Immunotherapy | At baseline and during each treatment cycle until disease progression, death, or last available liver function assessment, assessed up to 12 months. | 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. |
| Secondary | Change From Baseline in Child-Pugh Score During Immunotherapy | At baseline and each available treatment cycle until disease progression, death, or the last available liver function assessment, up to 12 months. | 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. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Summary Score | At baseline and every 3 months during follow-up, with additional assessment at disease progression or treatment discontinuation when feasible, up to 12 months. | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07904494
GET https://conductscience.org/api/trials/v1/NCT07904494/registered