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Balancing Tumor Response and Rejection Risk After Pre-Transplant Immunotherapy: A Scoping Review.

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Immune checkpoint inhibitors (ICIs) can help advanced liver cancer patients get a transplant, but require careful timing. A minimum 50-day washout period is recommended to reduce liver transplant rejection risk.

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Area of Science:

  • Transplant medicine
  • Immunology
  • Hepatobiliary oncology

Background:

  • Immune checkpoint inhibitors (ICIs) offer new treatment options for hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA), potentially enabling liver transplantation (LT).
  • The immunologic risks of pre-transplant ICI use, especially allograft rejection due to T-cell activation, are not fully understood.
  • This creates a knowledge gap between immuno-oncology and transplant medicine.

Purpose of the Study:

  • To review evidence on oncologic outcomes, rejection risk, washout intervals, donor factors, and immunosuppression in LT recipients with prior ICI exposure.
  • To synthesize findings on ICI use for HCC and CCA patients undergoing LT.

Main Methods:

  • A PRISMA-ScR-guided systematic review of studies from January 2015 to December 2025.
  • Searched MEDLINE, Embase, Cochrane Library, and Web of Science for adult LT recipients with pre-transplant ICI exposure for HCC or CCA.
  • Narrative synthesis of findings due to study heterogeneity; quality assessed using NOS and JBI tools.

Main Results:

  • Thirty studies included; neoadjuvant ICI therapy downstaged 75.6% of HCC patients to Milan criteria.
  • Complete pathologic response rates ranged from 23.8% to 40% in HCC.
  • Rejection rates were 16.3%-20.2% but rose to 56.3% with short washout; >50 days washout approached non-ICI control rates.
  • An estimated 94 days washout may be needed to achieve ≤20% rejection risk.
  • Rejection occurred earlier (median 7-10 days post-transplant); three-year overall survival exceeded 85.3%.
  • Immune-related adverse events correlated with higher rejection risk.

Conclusions:

  • Pre-transplant ICI therapy expands eligibility for advanced hepatobiliary malignancies but carries time-dependent rejection risks.
  • A minimum washout of 50 days is supported, with emerging data favoring 90-94 days.
  • Prospective studies, biomarker stratification, and standardized protocols are needed to optimize patient selection and timing.