Correlation and Heterogeneity of the Immune Microenvironment and Histopathological Growth Patterns in Resectable Colorectal Cancer Liver Metastases (CRLM)
27 de abril de 2026 actualizado por: Meng Qiu
Correlation and Heterogeneity of the Immune Microenvironment and Histopathological Growth Patterns in Resectable Colorectal Cancer Liver Metastases
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
This study aims to retrospectively analyze the status and spatial heterogeneity of the tumor microenvironment (TME) in liver metastases from patients with CRLM, as well as the association between HGPs at the tumor-liver interface and postoperative recurrence following resection of liver metastases.
Furthermore, this study seeks to explore the underlying mechanisms through which HGPs influence patient prognosis.
Tipo de estudio
De observación
Inscripción (Estimado)
64
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.
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Hospital of Sichuan University
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
This study enrolled patients with CRLM who underwent R0 resection.
Descripción
Inclusion Criteria:
- Patients with CRLM who underwent R0 resection
- Histologically or cytologically confirmed CRLM
- Have sufficient liver metastasis tissue specimens available for analysis
- Complete treatment and follow-up records
Exclusion Criteria:
- Patients did not undergo R0 resection
- Postoperative specimens were unavailable
- Clinical data were incomplete.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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patients with CRLM who underwent R0 resection
According to the 2017 guidelines on histopathological growth patterns of liver metastases, HGPs are primarily classified into three types: the desmoplastic histopathological growth pattern (dHGP), the replacement histopathological growth pattern (rHGP), and the pushing histopathological growth pattern (pHGP).
The tumor-liver interface was independently delineated by two pathologists using QuPath software, and distinct HGPs at the tumor-liver interface were identified.
Formalin-fixed, paraffin-embedded (FFPE) sections of colorectal cancer liver metastases were stained with hematoxylin and eosin (H&E).Multiplex immunohistochemistry (mIHC) staining was performed on FFPE sections of liver metastases using two panels (Panel 1: CD4, CD8A, Foxp3, PD-L1, Panck; Panel 2: CD68, CD163, FAP-α, α-SMA, Panck), encompassing a total of nine immune cell markers.
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Formalin-fixed, paraffin-embedded (FFPE) sections of colorectal cancer liver metastases were stained with hematoxylin and eosin (H&E) and Multiplex immunohistochemistry (mIHC) staining.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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OS(Overall survival)
Periodo de tiempo: OS is defined as the time from the date of the first liver metastasis resection to death due to any cause or loss to follow-up, assessed up to 100 months.
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OS was defined as the time from the date of the first liver metastasis resection to death due to any cause or loss to follow-up.
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OS is defined as the time from the date of the first liver metastasis resection to death due to any cause or loss to follow-up, assessed up to 100 months.
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RFS (Recurrence-free Survival)
Periodo de tiempo: From the date of liver resection until the first occurrence of a measurable recurrence of the disease, or until death due to any cause (whichever occurs first), the assessment period can be up to 100 months.
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The definition of recurrence-free survival is the time from the liver surgery to the first imaging evidence showing disease recurrence or death due to any cause, whichever occurs first.
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From the date of liver resection until the first occurrence of a measurable recurrence of the disease, or until death due to any cause (whichever occurs first), the assessment period can be up to 100 months.
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HGPs (Histopathological Growth Patterns)
Periodo de tiempo: From the completion of HE staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
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The histopathological growth pattern of the tumor-liver interface.
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From the completion of HE staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
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TME (Tumor Microenvironment)
Periodo de tiempo: From the completion of mIHC staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
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Multiplex immunohistochemistry (mIHC) staining was performed on FFPE sections of liver metastases using two panels (Panel 1: CD4, CD8A, Foxp3, PD-L1, Panck; Panel 2: CD68, CD163, FAP-α, α-SMA, Panck), encompassing a total of nine immune cell markers.
Using QuPath pathology imaging software, tissue sections were divided into the tumor center (defined as regions >500 μm from the liver-tumor interface) and the invasive tumor front (defined as a 1 mm region extending 500 μm on either side of the liver-tumor interface).
Quantitative analysis of immune cell populations was performed in the tumor center, the invasive tumor front, and regions corresponding to different histopathological growth patterns.
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From the completion of mIHC staining to the failure of staining or the damage and loss of the slides, the assessment period can be up to 100 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Stremitzer S, Vermeulen P, Graver S, Kockx M, Dirix L, Yang D, Zhang W, Stift J, Wrba F, Gruenberger T, Lenz HJ, Scherer SJ. Immune phenotype and histopathological growth pattern in patients with colorectal liver metastases. Br J Cancer. 2020 May;122(10):1518-1524. doi: 10.1038/s41416-020-0812-z. Epub 2020 Mar 24.
- Latacz E, Hoppener D, Bohlok A, Leduc S, Tabaries S, Fernandez Moro C, Lugassy C, Nystrom H, Bozoky B, Floris G, Geyer N, Brodt P, Llado L, Van Mileghem L, De Schepper M, Majeed AW, Lazaris A, Dirix P, Zhang Q, Petrillo SK, Vankerckhove S, Joye I, Meyer Y, Gregorieff A, Roig NR, Vidal-Vanaclocha F, Denis L, Oliveira RC, Metrakos P, Grunhagen DJ, Nagtegaal ID, Mollevi DG, Jarnagin WR, D'Angelica MI, Reynolds AR, Doukas M, Desmedt C, Dirix L, Donckier V, Siegel PM, Barnhill R, Gerling M, Verhoef C, Vermeulen PB. Histopathological growth patterns of liver metastasis: updated consensus guidelines for pattern scoring, perspectives and recent mechanistic insights. Br J Cancer. 2022 Oct;127(6):988-1013. doi: 10.1038/s41416-022-01859-7. Epub 2022 Jun 1.
- van Dam PJ, van der Stok EP, Teuwen LA, Van den Eynden GG, Illemann M, Frentzas S, Majeed AW, Eefsen RL, Coebergh van den Braak RRJ, Lazaris A, Fernandez MC, Galjart B, Laerum OD, Rayes R, Grunhagen DJ, Van de Paer M, Sucaet Y, Mudhar HS, Schvimer M, Nystrom H, Kockx M, Bird NC, Vidal-Vanaclocha F, Metrakos P, Simoneau E, Verhoef C, Dirix LY, Van Laere S, Gao ZH, Brodt P, Reynolds AR, Vermeulen PB. International consensus guidelines for scoring the histopathological growth patterns of liver metastasis. Br J Cancer. 2017 Nov 7;117(10):1427-1441. doi: 10.1038/bjc.2017.334. Epub 2017 Oct 5.
- Zhang A, Zhang Y, Xu J, Zhu R, Liang T, Guo L. Molecular landscape of colorectal cancer liver metastasis: Tumor microenvironment heterogeneity and driver inference. Crit Rev Oncol Hematol. 2025 Dec;216:104946. doi: 10.1016/j.critrevonc.2025.104946. Epub 2025 Sep 12.
- Liang JY, Xi SY, Shao Q, Yuan YF, Li BK, Zheng Y, Wang DS, Wu XJ, Ding PR, Chen G, Li LR, Wang FH, Wang ZQ, Pan ZZ, Xu RH, Li YH. Histopathological growth patterns correlate with the immunoscore in colorectal cancer liver metastasis patients after hepatectomy. Cancer Immunol Immunother. 2020 Dec;69(12):2623-2634. doi: 10.1007/s00262-020-02632-6. Epub 2020 Jun 29.
- He Y, Han Y, Fan AH, Li D, Wang B, Ji K, Wang X, Zhao X, Lu Y. Multi-perspective comparison of the immune microenvironment of primary colorectal cancer and liver metastases. J Transl Med. 2022 Oct 4;20(1):454. doi: 10.1186/s12967-022-03667-2.
- Hoppener DJ, Nierop PMH, Hof J, Sideras K, Zhou G, Visser L, Gouw ASH, de Jong KP, Sprengers D, Kwekkeboom J, Vermeulen PB, Grunhagen DJ, Verhoef C. Enrichment of the tumour immune microenvironment in patients with desmoplastic colorectal liver metastasis. Br J Cancer. 2020 Jul;123(2):196-206. doi: 10.1038/s41416-020-0881-z. Epub 2020 May 18.
Enlaces Útiles
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)
1 de enero de 2018
Finalización primaria (Estimado)
30 de diciembre de 2030
Finalización del estudio (Estimado)
30 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
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
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Técnicas de investigación
- Piranos
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Técnicas citológicas
- Hidrocarburos
- Hidrocarburos, cíclico
- Compuestos policíclicos
- Benzopirans
- Técnicas histológicas
- Compuestos heterocíclicos, 3 anillos
- Compuestos de Spiro
- Técnicas de preparación histocitológica
- Fluoresceínas
- Xantenes
- Hematoxylin
- Eosine Yellowish-(YS)
- Staining and Labeling
Otros números de identificación del estudio
- Approval No. 2021, 2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
First of all, there is a lack of sufficient funds or personnel to anonymize and maintain the data for a long time, such as the original imaging documents, which are difficult to organize compliance.
Second, this study was an early exploratory study with small data size and high risk of identification.
Finally, summary results are available after publication, and the data will be reassessed 5 years after the end of the study.
Datos del estudio/Documentos
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Plan de Análisis Estadístico
Identificador de información: qiumeng@wchscu.cnComentarios de información: Survival analysis was estimated using the Kaplan-Meier method and compared using the log-rank test. Quantitative data regarding the immune microenvironment were compared using the t-test or the Mann-Whitney U test, as appropriate. Changes between initial resection and secondary resection were analyzed using the nonparametric test for two paired samples. The endpoints of this study included patient clinical outcomes (OS and PFS), spatial distribution differences of immune cells within TME of liver metastases, distribution patterns of HGPs and their correlation with survival, and analysis of the immune microenvironment in relation to HGPs.
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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