Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
16 de agosto de 2026 actualizado por: Pei-Rong Ding, Sun Yat-sen University
This study aims to evaluate whether plasma molecular residual disease (MRD), assessed using circulating tumor DNA (ctDNA), can help optimize the duration of immunotherapy in patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.
Patients with MSI-H/dMMR metastatic colorectal cancer can achieve durable responses to immune checkpoint inhibitors, but the optimal duration of treatment remains uncertain. Prolonged immunotherapy may increase treatment burden and the risk of immune-related adverse events. ctDNA-based MRD testing may provide a sensitive method for detecting residual tumor burden and identifying patients who may be able to safely stop treatment.
In this study, patients receiving immunotherapy will undergo serial plasma MRD testing. After completing 1 year of immunotherapy, patients with two consecutive negative MRD results will be randomly assigned to either continue immunotherapy or stop treatment and enter observation. Patients will then be followed every 3 months for 2 years with MRD testing and routine clinical assessments, including imaging and laboratory examinations.
The study will compare clinical outcomes between the two groups and evaluate whether serial plasma MRD monitoring can support a more individualized approach to the duration of immunotherapy in MSI-H/dMMR metastatic colorectal cancer.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Binyi Xiao, M.D
- Número de teléfono: +86-15800004780
- Correo electrónico: xiaoby@sysucc.org.cn
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Reclutamiento
- Sun Yat-sen University Cancer Center
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Contacto:
- Binyi Xiao, M.D.
- Número de teléfono: +86-1580004780
- Correo electrónico: xiaoby@sysucc.org.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Voluntary participation in the study and provision of written informed consent.
- Age ≥18 years at the time of signing informed consent.
- Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.
- Clinically confirmed stage IV disease.
- No prior immunotherapy for the current colorectal cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Availability of adequate pretreatment tumor tissue and peripheral blood samples for whole-exome sequencing (WES) and personalized circulating tumor DNA (ctDNA)/MRD analysis.
- Life expectancy >12 months.
- Willing and able to comply with the study procedures and scheduled follow-up.
Exclusion Criteria:
- Presence of another malignancy.
- Prior immunotherapy for the current stage IV colorectal cancer.
- Organ transplantation within 3 months before enrollment.
- History of blood transfusion within 3 months before enrollment.
- Active, known, or suspected autoimmune disease, or evidence of active or chronic infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
- Pregnancy or breastfeeding.
- Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation.
- Failure to provide written informed consent.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: MRD-Guided Treatment Discontinuation
Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to discontinue immunotherapy.
Patients will enter observation and undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to discontinue immunotherapy.
Patients will enter observation and undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Comparador activo: Continued Immunotherapy
Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to continue immunotherapy for a total treatment duration of 2 years.
Patients will undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to continue immunotherapy for a total treatment duration of 2 years.
Patients will undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
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Otro: Observational Cohort
Patients who achieve disease control for at least 6 months after immunotherapy will undergo plasma MRD testing and prospective follow-up.
The study will not interfere with subsequent treatment decisions, including discontinuation or continuation of immunotherapy, surgery, or local treatment.
Patients will undergo routine clinical follow-up and serial MRD monitoring according to the study schedule.
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Patients who achieve disease control for at least 6 months after immunotherapy will undergo plasma MRD testing and prospective follow-up.
The study will not interfere with subsequent treatment decisions, including discontinuation or continuation of immunotherapy, surgery, or local treatment.
Patients will undergo routine clinical follow-up and serial MRD monitoring according to the study schedule.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression-Free Survival (PFS)
Periodo de tiempo: From randomization to disease progression, death, or up to 2 years
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Progression-free survival is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
Participants without disease progression or death will be censored at the date of the last disease assessment.
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From randomization to disease progression, death, or up to 2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival (OS)
Periodo de tiempo: From randomization to death from any cause or up to 3 years
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Overall survival is defined as the time from randomization to death from any cause.
Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive.
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From randomization to death from any cause or up to 3 years
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Incidence of Immune-Related Adverse Events (irAEs)
Periodo de tiempo: From randomization through 2 years of follow-up
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The incidence of immune-related adverse events will be assessed during the study.
The proportion of participants experiencing immune-related adverse events will be recorded and compared between the treatment-discontinuation and continued-immunotherapy groups.
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From randomization through 2 years of follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Peirong Ding, M.D., Sun Yat-sen University Cancer Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de junio de 2026
Finalización primaria (Estimado)
30 de diciembre de 2029
Finalización del estudio (Estimado)
30 de diciembre de 2034
Fechas de registro del estudio
Enviado por primera vez
16 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades del Colon
- Neoplasias colorrectales
- Técnicas de investigación
- Métodos
- Observación
Otros números de identificación del estudio
- G2025-013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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