NCT07904494Toborzás még nem indult
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Association Between Immune-Related Adverse Events and Therapeutic Efficacy of First-Line Immunotherapy in Unresectable Hepatocellular Carcinoma Patients
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
The goal of this observational study is to evaluate how well first-line immunotherapy works and investigate its association with immune-related adverse events (irAEs) in Egyptian adults with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The main questions this study aims to answer are: * Are immune-related adverse events (irAEs), which are side effects caused by activation of the immune system, associated with treatment response and survival? * How effective and safe is first-line immunotherapy in Egyptian patients with unresectable HCC? The study will also explore whether routine blood markers, including eosinophil counts and markers of inflammation and nutritional status, are associated with treatment outcomes and the development of immune-related side effects. Changes in liver function and patients' health-related quality of life will also be evaluated. Approximately 294 patients receiving first-line immunotherapy as part of their routine medical care will be included. Patients may receive atezolizumab plus bevacizumab or durvalumab plus tremelimumab, as prescribed by their treating physicians. Researchers will not assign treatments or change patients' medical care. The study will include a review of existing medical records and prospective follow-up of eligible patients. Researchers will: * Review medical records to collect information about treatment, routine blood tests, imaging results, side effects, and clinical outcomes. * Follow eligible patients during routine medical visits to assess treatment response, survival, adverse events, and changes in liver function. * Ask prospectively enrolled participants to complete questionnaires about their health-related quality of life during scheduled follow-up assessments. Researchers will compare treatment outcomes between patients who develop irAEs and those who do not, while taking into account when these side effects occur.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 294 (tervezett)
- Első benyújtás
- 2026. okt. 18.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2027. okt. 1.
- Fő szponzor
- Assiut University
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT07904494
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 294
- 2026. nov. 1. és az elsődleges befejezés (2027. okt. 1.) között
- 4 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Systemic therapy history: History of prior systemic anticancer therapy for hepatocellular carcinoma, including but not limited to tyrosine kinase inhibitors, chemotherapy, monoclonal antibodies, or immune checkpoint inhibitors, anti V-EGF.
- Mixed hepatocellular-cholangiocarcinoma or the presence of an additional primary malignancy requiring concurrent treatment.
Más betegség
- Autoimmune conditions: Active, severe autoimmune diseases requiring systemic immunosuppressive therapy.
- Tumor histology and malignancy:
Laborértékek
- Missing essential baseline, laboratory, imaging, or survival data.
Egyéb
- Liver function: Advanced liver decompensation is defined as any of the following Child-Pugh Class B8-9 or C, refractory ascites, or active hepatic encephalopathy.
- Performance status: Poor Performance Status (ECOG score > 2)
Kiket keres a vizsgálat
- Age: Adult patients (≥ 18 years)
- Diagnosis: Patients with histologically or radiologically confirmed uHCC, according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD).
- Disease stage: Unresectable, locally advanced, or metastatic disease, Barcelona Clinic Liver Cancer (BCLC) B or C.
- Systemic therapy eligibility: Eligible to receive first-line systemic immunotherapy-based combination regimens, as per institutional protocol at the time of treatment initiation, including:
- Atezolizumab plus Bevacizumab
- Durvalumab plus Tremelimumab
- Other approved standard-of-care combinations adopted during the study period
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- Liver function: Child-Pugh Class A or B (specifically Class A, 5-6 points, or Class B7, 7 points, only).
- Measurable disease: At least one measurable lesion on baseline radiological imaging, assessable according to RECIST version 1.1 or modified RECIST (mRECIST) criteria.
- Systemic therapy history: No prior systemic treatment for advanced or metastatic HCC. Prior locoregional therapy (e.g., TACE, HAIC, SBRT, ablation) is permitted if completed more than 4 weeks before immunotherapy initiation.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (4)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| El-Mabaraa Health Insurance Hospital | Asyut | Egyiptom | Ismeretlen állapot |
| Al-Rajhi University Hospital, Assiut University | Asyut | Egyiptom | Ismeretlen állapot |
| National Liver Institute, Menoufia University | Shibīn al Kawm | Egyiptom | Ismeretlen állapot |
| Menoufia Cancer Institute, Menoufia University | Shibīn al Kawm | Egyiptom | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.