Comparison of Atezolizumab/Bevacizumab Versus Durvalumab/Tremelimumab (STRIDE) Protocols in Local… (NCT07669597) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Atezolizumab/Bevacizumab Versus Durvalumab/Tremelimumab (STRIDE) Protocols in Locally Advanced or Metastatic Hepatocellular Carcinoma Among Patients in Sohag
Egypt50 participantsStarted 2026-03-01
Plain-language summary
This retrospective observational study compares two first-line immunotherapy-based treatment regimens used for adults with locally advanced or metastatic hepatocellular carcinoma (HCC) at Suhag Cancer Center, Egypt. The two regimens are atezolizumab plus bevacizumab and durvalumab plus tremelimumab, also known as the STRIDE regimen.
HCC is a major cancer burden in Egypt. Although both regimens have shown benefit in international clinical trials, they have not been directly compared in Egyptian patients. Differences in local disease patterns, comorbidities, access to treatment, and real-world tolerability may influence treatment outcomes. This study will use existing medical records and cancer registry data to compare outcomes between patients who received either regimen as first-line systemic therapy.
The primary aim is to compare the 12-month overall survival rate between the two treatment groups. Secondary aims include comparing progression-free survival, tumor response, disease control, severe treatment-related adverse events, and health-related quality of life. Tumor response will be assessed using RECIST 1.1 or modified RECIST criteria when available, and adverse events will be graded according to CTCAE version 5.0.
Eligible patients are adults with confirmed locally advanced or metastatic HCC who were not candidates for curative surgical or locoregional treatment and who started one of the two regimens between January 2021 and December 2024. Data will be collected retrospectively from registry and hospital records. Because this is a retrospective review of existing records, informed consent was waived by the institutional ethics committee, and patient data will be handled confidentially and anonymized.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 of informed consent.
* Laboratory and radiologically confirmed diagnosis of unresectable or metastatic hepatocellular carcinoma.
* No prior systemic therapy for HCC.
* Child-Pugh liver function class A (score 5-6).
* ECOG performance status of 0 or 1.
* Adequate haematologic and organ function as defined by: o Hemoglobin ≥ 9 g/dL o Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L o Platelets ≥ 75 × 10⁹/L o Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min o AST and ALT ≤ 5 × ULN (≤ 3 × ULN if no liver involvement) o ULN Total bilirubin ≤ 2 × 7.
* Willingness to comply with study procedures and follow-up schedule.
* Signed written informed consent obtained prior to any study-related procedures.
Exclusion Criteria:
* History of autoimmune disease requiring systemic immunosuppressive therapy.
* Untreated or high-risk gastro-oesophageal varices as defined by institutional standards.
* Prior liver transplantation or diagnosis of another active malignancy (excluding localized skin cancer or cervical carcinoma in situ) within the past three years.
* Patients with high-risk oesophageal varices.
* Patients with portal vein thrombosis.
* Known HIV infection or active hepatitis B/C with uncontrolled viraemia.
* Uncontrolled cardiovascular or thromboembolic disease (e.g., recent myocardial infarction, stroke, or pulmonary embolism within 6 months).
* Active bleeding, coagulopathy, or platelet disorders contraindicating bevacizumab.
* Lactation.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
12-Month Overall Survival Rate
Timeframe: 12 months after initiation of first-line systemic therapy