NCT07669597Fut, nem toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 25.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 50 (tervezett)
- Első benyújtás
- 2026. jún. 20.
- Kezdés
- 2026. márc. 1.
- Elsődleges befejezés
- 2027. márc. 1.
- Fő szponzor
- Sohag Oncology Center
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT07669597
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 50
- 2026. márc. 1. és az elsődleges befejezés (2027. márc. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior liver transplantation or diagnosis of another active malignancy (excluding localized skin cancer or cervical carcinoma in situ) within the past three years.
Más betegség
- 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).
Laborértékek
- Active bleeding, coagulopathy, or platelet disorders contraindicating bevacizumab.
Egyéb
- Untreated or high-risk gastro-oesophageal varices as defined by institutional standards.
- Patients with high-risk oesophageal varices.
- Lactation.
- Pregnancy.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sohag Oncology Center | Sohag | Egyiptom | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.