SCRT Combined With CAPOX and PD-1 Antibody Versus LCRT Combined With CAPOX for Early Low-lying Rectal Cancer (TORCH-E3) (TORCH-E3)
A Prospective, Randomized, Phase III Clinical Trial Comparing Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for the Treatment of Early-stage Low Rectal Cancer.
TORCH-E3 is a prospective, multicentre, randomized phase III trial. 394 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is 3y TME-free survival. The secondary endpoints include complete response (CR, pathological complete response [pCR] plus cCR) rate, the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhen Zhang, M.D, PH.D
- Número de teléfono: 18801735029
- Correo electrónico: zhen_zhang@fudan.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Yajie Chen Chen, PH.D
- Número de teléfono: 18917239680
- Correo electrónico: 16111230008@fudan.edu.cn
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Fudan University Shanghai Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age 18-75 years old, female and male
- pathological confirmed adenocarcinoma
- clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm
- the distance from anal verge less than 5 cm
- without distance metastases
- KPS >=70
- with good compliance
- microsatellite repair status is MSS/pMMR
- without previous anti-cancer therapy or immunotherapy
- signed the inform consent
Exclusion Criteria:
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pregnancy or breast-feeding women
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pathological confirmed signet ring cell carcinoma
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clinical stage T1N0 and can be resected locally
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history of other malignancies within 5 years
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serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
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immunodeficiency disease or long-term using of immunosuppressive agents
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baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST
- 2.5 ULN, Cr≤ 1 ULN
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DPD deficiency
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allergic to any component of the therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: SCRT plus immunochemotherapy group
Patients will receive SCRT (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option. |
SCRT: 25Gy/5Fx Sintilimab 200mg d1 q3w
Otros nombres:
Oxaliplatin: 130mg/m2 d1 q3w Xeloda |
|
Otro: LCRT plus chemotherapy group
Patients will receive LCRT (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option. |
Oxaliplatin: 130mg/m2 d1 q3w Xeloda LCRT: 50Gy/25Fx |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
3 year TME-free survival rate
Periodo de tiempo: the proportion of patients who remain alive and have not undergone total mesorectal excision (TME) surgery within three years from the start of treatment.
|
Rate of 3 year TME-free survival |
the proportion of patients who remain alive and have not undergone total mesorectal excision (TME) surgery within three years from the start of treatment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
3 year local recurrence free survival rate
Periodo de tiempo: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
Rate of 3 year local recurrence free survival |
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
|
complete response (CR) rate
Periodo de tiempo: 1 month after the surgery or the decision of W&W
|
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. |
1 month after the surgery or the decision of W&W
|
|
Organ preservation rate
Periodo de tiempo: from date of receiving neoadjuvant therapy, assessed up to 3 years
|
Organ preservation rate |
from date of receiving neoadjuvant therapy, assessed up to 3 years
|
|
3 year disease free survival rate
Periodo de tiempo: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
|
Rate of 3 year disease free survival |
From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
|
|
3 year overall survival rate
Periodo de tiempo: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months
|
Rate of 3 year overall survival |
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months
|
|
3 year Quality of Life
Periodo de tiempo: From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
|
Quality of life will be evaluated using EORTC QLQ-C30 score. |
From date of initiation of treatment until the date of death from any cause, assessed up to 3 years
|
|
Grade 3-4 adverse effects rate
Periodo de tiempo: From date of randomization until 3 months after the completion neoadjuvant therapy
|
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events |
From date of randomization until 3 months after the completion neoadjuvant therapy
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Ácidos nucleicos, nucleótidos y nucleósidos
- Complejos de coordinación
- Desoxicitidina
- Citidina
- Nucleósidos de pirimidina
- Pirimidinas
- Nucleósidos
- Uracílico
- Pirimidinonas
- Desoxirribonucleósidos
- Fluorouracil
- Capecitabina
- Oxaliplatino
- sintilimab
Otros números de identificación del estudio
- FDRT-2026-388-5240
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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