NCT07669597Active, not recruiting
Comparison of Atezolizumab/Bevacizumab Versus Durvalumab/Tremelimumab (STRIDE) Protocols in Locally Advanced or Metastatic Hepatocellular Carcinoma Among Patients in Sohag
Retrospective Comparison of Atezolizumab/Bevacizumab Versus Durvalumab/Tremelimumab (STRIDE) Protocols in Locally Advanced or Metastatic Hepatocellular Carcinoma Among Patients in Suhag Cancer Center, Egypt
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 20 Jun 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Sohag Oncology Center
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07669597
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Mar 2026 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior liver transplantation or diagnosis of another active malignancy (excluding localized skin cancer or cervical carcinoma in situ) within the past three years.
Other illness
- History of autoimmune disease requiring systemic immunosuppressive therapy.
- 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).
Lab values
- Active bleeding, coagulopathy, or platelet disorders contraindicating bevacizumab.
Other
- Untreated or high-risk gastro-oesophageal varices as defined by institutional standards.
- Patients with high-risk oesophageal varices.
- Lactation.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sohag Oncology Center Coordinator of this site? Confirm its status | Sohag | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.