- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07919418
A Patient-Derived 3D Bioprinted Colorectal Cancer-Stroma-Immune Triad Model Uncovers Microenvironmental Mechanisms of Chemoresistance and Immune Evasion
Construction of a 3D Multicellular Bioprinted Human Colorectal Cancer Immune-Stromal Microenvironment Model and Its Clinical Translational Research
Colorectal cancer (CRC) has shifted toward a patient-personalized precision medicine paradigm; however, the high heterogeneity and complex tumor microenvironment (TME) of CRC restrict the development of individualized therapy, and existing preclinical models and multi-omics technologies are insufficient to broadly benefit patients. Building on previous research, this project intends to use 3D multicellular bioprinting (3DMP) to incorporate key TME components-cancer-associated fibroblasts (CAFs) and PBMC immune cells-to construct patient-derived CRC-CAFs/PBMC 3DMP models, aiming to apply them to personalized clinical drug screening and prognosis prediction, and to combine them with multi-omics technologies to advance preclinical research on CRC. The implementation of this study will help address the bottleneck of the lack of broadly applicable preclinical models for advancing CRC precision therapy. It has major clinical translational value, will bring significant changes to CRC preclinical research platforms, and will help promote the development of cancer precision medicine.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yilei Mao, MD PHD
- Número de teléfono: 8600-010-69156042
- Correo electrónico: pumch-liver@hotmail.com
Ubicaciones de estudio
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Zhejiang
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Ningbo, Zhejiang, Porcelana
- Reclutamiento
- Ningbo Medical Center Lihuili Hospital
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Contacto:
- Zhou Bo
- Número de teléfono: 8600-0574-87018701
- Correo electrónico: 1955729746@qq.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Clinically and pathologically proven colorectal cancer patients are considered as potential candidates of this study. Medical history will be thouroughly taken by clincal practicitioners. Only patients older than 18 years will be included. Those with medical hostory of other malignancies or serious diseases will be excluded. Patients who are not able to sign the informed consent independently will not be included in this study. All the patients included in this study will receive adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of CRC.
Descripción
Inclusion Criteria:
- More than 18 years old
- Diagnosed as colorectal cancer with or without liver metastases before
- Pathologically proven colorectal cancer after surgery
Exclusion Criteria:
- Medical history with other malignancies or serious diseases
- Disable to sign the informed consent independently
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Patients with colorectal cancer who underwent surgical resection received adjuvant chemotherapy
Surgical resection will be performed for locoregional lesions. Regimens of adjuvant chemotherapy are directed by clinical guidance and experience. |
Surgical resection will be performed for locoregional lesions. Regimens of adjuvant chemotherapy are directed by clinical guidance and experience. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.
Periodo de tiempo: 2025.05-2026.12
|
The investigators will establish and culture 3D colorectal cancer models and organoids. The 3D models and organoids will be treated with the same chemotherapy drugs as the corresponding patients. The viability of the 3D tumor models and organoids will be observed after treatment and the IC50 of each drug will be calculated. The correlation of 3D model/organoid sensitivity and the patient response will be analyzed. |
2025.05-2026.12
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Response of the colorectal cancer patients to adjuvant chemotherapy.
Periodo de tiempo: 2025.05-2026.12
|
The response to adjuvant chemotherapy will be evaluated according to PFS. Regular follow-ups will be conducted, and PFS is difined as the interval between the date of surgery and the date of last follow-up or recurrence/progression. |
2025.05-2026.12
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yilei Mao, MD PHD, Peking Union Medical College Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
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
- Terapéutica
- Terapia con drogas
- Terapia de modalidad combinada
- Quimioterapia, adyuvante
Otros números de identificación del estudio
- CRC-CAFs-3DP-Bioprint
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
Marco de tiempo para compartir IPD
The IPD data will available after the study is completed.
Criterios de acceso compartido de IPD
Data can be accessed via e-mail with reasonable requests.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .