Retrospective Comparison of Atezolizumab/Bevacizumab Versus Durvalumab/Tremelimumab (STRIDE) Protocols in Locally Advanced or Metastatic Hepatocellular Carcinoma Among Patients in Suhag Cancer Center, Egypt
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
Hepatocellular carcinoma (HCC) is a major public health problem in Egypt and remains an important cause of cancer-related mortality. The first-line treatment landscape for unresectable or advanced HCC has changed substantially with the introduction of immune checkpoint inhibitor-based regimens. Atezolizumab plus bevacizumab and durvalumab plus tremelimumab (STRIDE regimen) are both used as first-line systemic treatment options. However, there is no prospective head-to-head trial directly comparing these two regimens in Egyptian patients. Real-world local data are therefore needed to support treatment selection in routine clinical practice.
This is a retrospective, observational cohort study conducted at Suhag Cancer Center, Egypt. The study compares the real-world effectiveness, safety, and health-related quality of life outcomes of atezolizumab plus bevacizumab versus durvalumab plus tremelimumab in adults with locally advanced or metastatic HCC who received either regimen as first-line systemic therapy.
The study population includes eligible patients who initiated either atezolizumab plus bevacizumab or durvalumab plus tremelimumab between January 2021 and December 2024. Patients must be 18 years or older, have histologically or radiologically confirmed HCC according to international diagnostic guidelines, have an Eastern Cooperative Oncology Group performance status of 0 or 1, have locally advanced or metastatic disease not amenable to curative surgical or locoregional treatment, and have at least one follow-up visit with complete clinical and radiologic records available.
Patients will be excluded if they are younger than 18 years; have an Eastern Cooperative Oncology Group performance status of 2 or higher; have autoimmune disease requiring systemic immunosuppressive therapy; have prior liver transplantation or another active malignancy within the past three years, except localized skin cancer or cervical carcinoma in situ; have known HIV infection or uncontrolled active hepatitis B or C viremia; have uncontrolled cardiovascular or thromboembolic disease such as recent myocardial infarction, stroke, or pulmonary embolism within 6 months; have known central nervous system metastases or leptomeningeal disease; or are pregnant or lactating.
Data will be retrospectively retrieved from the Suhag Cancer Center cancer registry and hospital medical records. Extracted variables will include demographic characteristics, clinical characteristics, treatment details, response assessments, survival outcomes, adverse events, and health-related quality of life information. Clinical variables will include age, sex, Eastern Cooperative Oncology Group performance status, Child-Pugh score, Barcelona Clinic Liver Cancer stage, vascular invasion, and extrahepatic metastases. Treatment variables will include regimen type, number of cycles received, dose modifications, and reasons for treatment discontinuation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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 ×
- •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.
- •Pregnancy.