Organ-Specific Differences in Immunotherapy Response Among Metastatic Cancer Patients
Real-world Evidence and Multi-omics Insights Into Differential Immunotherapy Responses Between Primary and Metastatic Sites
This study examines how tumors in different metastatic organs respond to immune checkpoint inhibitor (ICB) therapy in real-world clinical practice. ICB therapy helps the immune system recognize and attack cancer cells, but treatment responses may vary depending on where the cancer has spread. Common metastatic sites such as the liver, brain, lung, and bone each have unique immune environments that may influence treatment outcomes.
The investigators will review the medical records of approximately 1,000 adults with solid tumors who received ICB therapy at Sun Yat-sen Memorial Hospital, the Third Affiliated Hospital of Sun Yat-sen University, and the First Affiliated Hospital of Chongqing Medical University since 2016. The study will compare treatment response, time until disease progression, and overall survival among patients with different metastatic sites. Additional outcomes include disease control, immunotherapy-related side effects, and concordance between primary and metastatic tumor responses.
The study will also analyze available molecular and immune-profiling datasets to explore biological mechanisms that may explain organ-specific differences in ICB response. The goal is to improve understanding of how metastatic sites influence immunotherapy effectiveness and to support future treatment decision-making.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age ≥18 years.
- Pathologically confirmed solid tumor with a documented primary tumor site.
- At least one metastatic site in the brain, liver, lung, or bone confirmed by imaging or pathology (single or multiple lesions allowed).
- Received first-line or second-line immune checkpoint inhibitor (ICB) therapy, including PD-1, PD-L1, or CTLA-4 inhibitors, either alone or in combination.
- Completed at least 3 cycles of ICB therapy.
- At least one evaluable imaging follow-up after initiation of immunotherapy.
- Available clinical and follow-up data, including treatment initiation date, response assessment, progression status, and survival status.
- Meets institutional ethics requirements for retrospective studies.
Exclusion Criteria:
- Unclear or undocumented metastatic site, or lack of imaging/pathologic evidence supporting metastasis.
- ICB treatment regimen cannot be clearly determined (e.g., unclear combination therapy components).
- Missing more than 20% of key clinical variables or incomplete follow-up data (e.g., missing PFS or OS information).
- Received fewer than 3 cycles of ICB therapy.
- Major treatment interruption or poor treatment adherence.
- Concurrent active malignancy that may interfere with outcome assessment.
- Severe immune-related disease (e.g., systemic lupus erythematosus) or organ transplantation requiring long-term immunosuppression.
- Participation in another interventional clinical trial that may affect treatment evaluation.
- Data errors or logical inconsistencies that cannot be resolved after review.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Metastatic cancers treated with immune checkpoint inhibitors
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Organ-Specific Objective Response Rate (osORR)
Periodo de tiempo: At first radiographic assessment after immunotherapy initiation (approximately 6-12 weeks).
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osORR is the percentage of patients whose tumors in a specific metastatic organ (brain, liver, lung, or bone) achieve a complete response (CR) or partial response (PR) following immunotherapy, as assessed according to RECIST v1.1.
Each metastatic organ is evaluated separately.
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At first radiographic assessment after immunotherapy initiation (approximately 6-12 weeks).
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Organ-Specific Progression-Free Survival (osPFS)
Periodo de tiempo: Up to 5 years.
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osPFS is defined as the time from initiation of immunotherapy to disease progression within the specific metastatic organ or death from any cause, whichever occurs first.
Progression is assessed according to RECIST v1.1 based on target lesions within the corresponding organ, regardless of progression occurring in other organs.
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Up to 5 years.
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Overall Survival (OS)
Periodo de tiempo: From start of ICB treatment until death from any cause (up to 5 years).
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In this retrospective study, OS is defined as the time from initiation of immune checkpoint blockade (ICB) therapy to death from any cause.
Survival time is determined using available longitudinal follow-up records.
Patients who are alive at the last follow-up will be censored.
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From start of ICB treatment until death from any cause (up to 5 years).
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- SYSKY-2025-902-01
Plan de datos de participantes individuales (IPD)
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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.
producto fabricado y exportado desde los EE. UU.
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