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by Estudio Clínico Chile
Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)
DESCRIPCIÓN
Este es un estudio fase 3 diseñado para evaluar la seguridad y eficacia de ATEZOLIZUMAB más LENVATINIB o SORAFENIB versus LENVATINIB o SORAFENIB en carcinoma hepatocelular avanzado que ha progresado a una primera línea con ATEZOLIZUMAB y BEVACIZUMAB.
Tumor Primario: Hepatocarcinoma
Fase: 3
Rama de tratamiento:
- A: ATEZOLIZUMAB + (LENVATINIB O SORAFENIB)
- B: LENVATINIB O SORAFENIB
Criterios de inclusión: 2L post 1L con Atezoliaumab + Bevacizumab
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.
- Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, or 2 subsequent tumor assessments, whichever is longer.
- At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization
- Child-Pugh class A within 7 days prior to randomization
- Adequate hematologic and end-organ function
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