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Study identifier: NCT05475613 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Downstaging Protocol Containing Immunotherapy for HCC Beyond the Milan Criteria Before Liver Transplantation

Condition: Liver Transplantation · Hepatocellular Carcinoma  ·  Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

PhasePhase 2
Planned participants59
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Hepatocellular Carcinoma (HCC) is the most common liver malignancy and the third leading cause of cancer death worldwide. Due to the shortage of donor organs and the risk of tumor recurrence after transplantation, the restrictive Milan criteria is the standard guideline for liver transplantation (LT) in patients with HCC and liver cirrhosis. The XXL study (Mazzaferro et al, 2020) is the first prospective trial validating that effective and sustained downstage therapy could expand the selection criteria and improve the prognosis of recipients with HCC beyond Milan criteria. However, the optimal DT protocol is poorly defined, especially in the Asian population. Recently, immunotherapies such as immune-checkpoint inhibitors (ICIs) are revolutionizing the management of advanced HCC, the combination of the ICI and other treatment regimens (Anti-VEGF, locoregional therapies et al) produced superior results in patients with advanced-stage HCC compared to those with traditional therapeutic regimens. Therefore, we hypothesize an intensive downstage regimen containing immunotherapy could expand the selection criteria for HCC LT

This description comes directly from the study's public registry record.

Talk to the study team

Li PANG, PhD  ·  +86 13622860325  ·  pangli5@mail.sysu.edu.cn

Leibo Xu, PhD  ·  +86-18819182396  ·  xuleibo3@mail.sysu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, Guangdong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT05475613