Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
Sintilimab Combined With Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy vs. Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy for Total Neoadjuvant Therapy in Patients With Mismatch Repair-Proficient (pMMR) or Microsatellite Stable/Low Microsatellite Instability (MSS/MSI-L) Locally Advanced Rectal Cancer: A Multicenter, Randomized, Double-Blind, Controlled Phase III Study
This is a randomized, double-blind, controlled, Phase III clinical study to evaluate the efficacy and safety of sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy, which is planned to enroll 500 subjects with locally advanced rectal cancer.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanxi Pu
- Número de teléfono: +86-18523197816
- Correo electrónico: yanxi.pu@innoventbio.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Sun Yat sen University Cancer Center
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Contacto:
- Ruihua Xu
- Número de teléfono: +86-20-87343468
- Correo electrónico: xurh2@sysucc.org.cn
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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
- Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
- Histopathologically confirmed locally advanced rectal adenocarcinoma, with clinical stage cT3-4NanyM0 or cT1-2N1-2M0 as defined by the AJCC 8th edition, and assessed as amenable to R0 resection after neoadjuvant therapy. MRI demonstrates that the lower edge of the tumor is within 10 cm from the anal verge.
- Tumor pathological tissue testing confirms pMMR, i.e., immunohistochemical staining shows positive expression of all four proteins MLH1, MSH2, MSH6, and PMS2, or tumor tissue-based genetic testing indicates MSI-L or MSS.
- No signs of intestinal obstruction; or intestinal obstruction that has been relieved after proximal colostomy.
- No prior rectal surgery; no prior systemic anti-cancer therapy, or other investigational drug therapy.
- Age ≥18 years, both sexes eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Expected survival of ≥2 years.
- Adequate bone marrow and organ function. Exclusion Criteria
1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
2. Plans to receive other anti-tumor therapy during the treatment period of this study.
3. Receipt of any live vaccine within 4 weeks before the first dose of study drug, or plans to receive any live vaccine during the study period.
4. Presence of toxicity from prior therapy that has not recovered to Grade 0 or 1 per NCI CTCAE V6.0 before the first dose of study drug (excluding alopecia, fatigue, pigmentation, and other conditions judged by the investigator to pose no safety risk).
5. Major surgery 6. Receipt of immunosuppressive therapy within 4 weeks before the first dose of study drug, excluding topical corticosteroids administered intranasally, by inhalation, or by other local routes, or physiological doses of systemic corticosteroids , or corticosteroids used to prevent contrast agent allergy.
7. Recurrent rectal cancer; multiple primary colorectal cancers. 8. History of pelvic or abdominal radiotherapy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
Placebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
130 mg/m²，IV，Q3W 20 ml D1 IV Q3W PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) 825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； Radical resection of rectal cancer |
|
Experimental: Sintilimab
sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
130 mg/m²，IV，Q3W PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) 825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； Radical resection of rectal cancer 200 mg D1 IV Q3W |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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EFS
Periodo de tiempo: throutg treatment completion an average of 5 years
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EFS refers to the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, death from any cause, etc. |
throutg treatment completion an average of 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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OS
Periodo de tiempo: throutg treatment completion an average of 5 years
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OS is defined as the time from the date of randomization until the date of death from any cause. |
throutg treatment completion an average of 5 years
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CCR
Periodo de tiempo: up to 5 years after enrollment
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CCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR) |
up to 5 years after enrollment
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R0 resection rate
Periodo de tiempo: up to 5 years after enrollment
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R0 resection rate: Descriptive summary of R0 resection rate |
up to 5 years after enrollment
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EFS3
Periodo de tiempo: 3yaers
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EFS3 defined as the proportion of participants who remain free from any of the following events for 3 years after randomization: disease progression precluding surgery, local or distant recurrence, or death from any cause |
3yaers
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TRG
Periodo de tiempo: up to 5 years after enrollment
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Pathological assessment of tumor regression grading (TRG) after neoadjuvant therapy |
up to 5 years after enrollment
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neoadjuvant therapy completion rate
Periodo de tiempo: up to 5 years after enrollment
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Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate |
up to 5 years after enrollment
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OPR
Periodo de tiempo: up to 5 years after enrollment
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The definition of organ preservation is: no radical total mesorectal excision (TME) performed, and no local regrowth, unless such regrowth can be salvaged by local excision achieving a limited, radical (R0) resection, with no permanent stoma (including a protective stoma that has never been reversed, or a stoma resulting from adverse events and/or poor functional outcome, or a permanent stoma). |
up to 5 years after enrollment
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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
- Terapéutica
- Ácidos nucleicos, nucleótidos y nucleósidos
- Complejos de coordinación
- Desoxicitidina
- Citidina
- Nucleósidos de pirimidina
- Pirimidinas
- Nucleósidos
- Uracílico
- Pirimidinonas
- Desoxirribonucleósidos
- Fluorouracil
- Capecitabina
- Oxaliplatino
- Radioterapia
- sintilimab
Otros números de identificación del estudio
- CIBI308H301
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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