Trial · NCT07904494
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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. |
| Secondary | Change From Baseline in EORTC QLQ-HCC18 Index 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. | 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. |
| Secondary | Change From Baseline in Absolute Eosinophil Count (AEC) During Immunotherapy | 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. | 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. |
| Secondary | Exploratory Real-World Comparison of Effectiveness and Safety Between First-Line Immunotherapy Regimens in Egypt | 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. | 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 |
| Secondary | Change From Baseline in Prognostic Nutritional Index (PNI) During Immunotherapy | 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. | 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. |
| Secondary | Change From Baseline in Neutrophil-to-Lymphocyte Ratio (NLR) During Immunotherapy | 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. | 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. |
| Secondary | Change From Baseline in Platelet-to-Lymphocyte Ratio (PLR) During Immunotherapy | 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. | 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. |
| Secondary | Change From Baseline in Systemic Immune-Inflammation Index (SII) During Immunotherapy | 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. | 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). |
| Secondary | Change From Baseline in Systemic Inflammation Response Index (SIRI) During Immunotherapy | 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. | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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