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NCT07228832
Estudio de fase III con ivonescimab o bevacizumab en combinación con FOLFOX en pacientes con cáncer colorrectal metastásico.
Reclutando
Fase 3
Descripción
Un estudio clínico aleatorizado, controlado con un grupo activo, doble ciego, multicéntrico, de fase 3, para evaluar ivonescimab en combinación con mFOLFOX6 (oxaliplatino, leucovorina y 5-fluorouracilo) frente a bevacizumab en combinación con FOLFOX para el tratamiento de primera línea del cáncer colorrectal metastásico (HARMONi-GI3).
Evidencia documentada
Eficacia publicada para la diana/fármaco de este ensayo en cáncer colorrectal. Se refiere al fármaco o a la diana molecular, no a este ensayo concreto, y no confirma elegibilidad. Revísalo siempre con tu oncólogo.
| Fármaco / régimen | ORR | SLP (m) | Fase / n | Evidencia | Fuente |
|---|---|---|---|---|---|
| FOLFIRI-cetuximab then mFOLFOX6-bevacizumab este fármaco | 82.4% | — | Phase 3 / n=131 | 1 | PMID 41980919 |
| Standard care (chemotherapy ± bevacizumab) este fármaco | — | 7.1 | Phase 3 | 1 | PMID 40444708 · 2026 |
| OPTIMOX-bevacizumab then FOLFIRI-bevacizumab then EGFR monoclonal antibody +/- irinotecan este fármaco | 65.4% | — | Phase 3 / n=132 | 1 | PMID 41980919 |
| Standard care (chemotherapy with or without bevacizumab) este fármaco | — | 7.1 | Phase 3 | 1 | PMID 40444708 |
| FOLFOXIRI + Bevacizumab este fármaco | 56% | 7.5 | Phase 3 / n=28 | 2A | PMID 33539752 · 2019 |
| FOLFOXIRI + Bevacizumab este fármaco | 56% | 7.5 | Phase 3 / n=28 | 2A | PMID 30514390 · 2019 |
Criterios de Elegibilidad
Criterios de inclusión:
1. Puntuación en la escala de ECOG de 0 o 1.
2. Esperanza de vida prevista ≥ 6 meses.
3. Pacientes con CRC metastásico confirmado histológica o citológicamente.
4. Sin terapia sistémica previa para CRC metastásico.
5. Al menos 1 lesión no cerebral medible.
Criterios de exclusión:
1. Enfermedad con inestabilidad de microsatélites alta (MSI-H) o deficiencia en la reparación de desajustes (dMMR).
2. Estado mutante conocido de BRAF V600E.
3. Presencia actual de manifestaciones radiográficas o clínicas significativas de obstrucción gastrointestinal (GI).
4. Ascitis que requiera paracentesis en los últimos 30 días.
5. Pacientes que hayan recibido inmunoterapia o terapia antiangiogénica previa para el cáncer colorrectal.
6. Enfermedad inflamatoria intestinal activa o antecedentes de la misma (p. ej., enfermedad de Crohn, colitis ulcerosa o diarrea crónica).
7. Enfermedad resecable.
Información del Ensayo
NCT07228832
Reclutando
Fase 3
600 participantes
Nov 2025
May 2028
Ubicaciones130
Belgium (4)
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Brussels
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Ghent
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Haine-Saint-Paul
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Kortrijk
Canada (3)
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Montreal
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Regina
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Toronto
Czechia (2)
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Hradec Králové
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Prague
France (7)
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Lyon
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Nantes
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Pierre-Bénite
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Strasbourg
Germany (2)
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Bonn
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Hamburg
Japan (17)
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Aichi
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Spain (10)
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United Kingdom (4)
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United States (78)
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