Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer
Intervencionista
Fase 2
Fujian Cancer Hospital
Patrocinador: Fujian Cancer Hospital
Última actualización: 15 de noviembre de 2023 Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors.
This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.
Mostrar descripción detallada
Categoría de tratamiento
Quimioterapia, Inhibidores de puestos de control, Otros medicamentos
* Patients with metastatic pMMR or MSS colorectal adenocarcinoma. Note: MMR or MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
* Patients who are naïve to systemic treatment in metastatic setting.
* Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was completed > 12 months before inclusion.
* Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.
* Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Criterios de exclusión
* Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
* Patients with metastatic disease amenable to be resected with potentially curative surgery
* Patients who have received any systemic treatment for metastatic disease.
* Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
* Patients who had received radiation within 14 days prior to the first dose of study drug
¿Cree usted que este ensayo clínico se muestra por error?
Detalles del diseño
AsignaciónN/A
Modelo de intervenciónSingle Group Assignment
EnmascaramientoNone (Open Label)
Número a inscribir20
Brazos e Intervenciones
Brazos
Intervenciones
Tipo: Experimental
Descripción: Cadonilimab (6mg/kg, iv, Q2W, Day1)+irinotecan* 165 mg/m² iv continue for 1.5 hours, D1; oxaliplatin 85 mg/m² iv continue for 2 hours, D1; leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours, D1; 5-FU 2400 mg/m² cont. inf. 48h; repeat every 2 weeks (Q2W) + bevacizumab （5mg/kg，d 1）
Intervenciones:
Oxaliplatin
irinotecan
5-FU
cadonilimab
leucovorin or levoleucovorin
Medidas de resultado
Medidas de resultado primarias
Overall Response Rate (ORR)Up to two years
RECIST 1.1
Medidas de resultado secundarias
Progression free survival (PFS)Up to two years
RECIST 1.1
Guardar ensayo
Compartir ensayo
Descargar ensayo
¿Cree usted que este ensayo clínico se muestra por error?