doi:10.70996/cip.00002

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癌症免疫观点 ›› 2025, Vol. 1 ›› Issue (1) : 12-19. DOI: 10.70996/cip.00002

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Immune-Related Biomarkers in Cancer: Development, Validation, and Challenges in Clinical Practice—A Systematic Review

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Abstract

Cancer immunotherapy, particularly immune checkpoint inhibitors (ICIs), has fundamentally transformed oncology treatment

over the past decade, markedly improving survival across multiple tumor types. However, response rates remain limited, with

only 15-30% of patients deriving clinical benefit, highlighting the critical need for reliable predictive biomarkers. This

systematic review comprehensively examines the current landscape of immune-related biomarkers in cancer, focusing on their

development, validation methodologies, and challenges in clinical translation. We analyze biomarker categories including

tumor microenvironment-based markers (PD-L1, TMB), peripheral blood markers (autoantibodies, inflammatory indices), and

emerging multi-omics approaches. The review further explores the complex validation pathway for clinical implementation,

addressing persistent obstacles such as tumor heterogeneity, technical standardization, and biological complexity. Finally, we

discuss innovative strategies and future directions aimed at enhancing biomarker performance through multi-omics integration,

artificial intelligence, and novel trial designs. The continued evolution of biomarker development holds significant promise for

advancing precision immuno-oncology and optimizing patient outcomes

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[J]. 癌症免疫观点. 2025, 1(1): 12-19 https://doi.org/10.70996/cip.00002

Yu Liu, Liang Li.

Immune-Related Biomarkers in Cancer: Development, Validation, and Challenges in Clinical Practice—A Systematic Review

[J]. Cancer Immuno Perspectives. 2025, 1(1): 12-19 https://doi.org/10.70996/cip.00002

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