RecruitingPhase 2NCT05475613

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

A Prospective, Single-arm Study of Downstaging Protocol Containing Immunotherapy for HCC Beyond the Milan Criteria Before Liver Transplantation


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

59 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination "downstaging" treatment approach — using immunotherapy and other liver-directed therapies — to try to shrink liver cancer (hepatocellular carcinoma, or HCC) that is currently too large or widespread to qualify for a liver transplant, with the goal of making patients eligible for transplant. **You may be eligible if...** - You have been diagnosed with hepatocellular carcinoma (HCC) that exceeds the "Milan criteria" (the size/number thresholds used to qualify for liver transplant) but has not spread outside the liver - Your liver function is reasonably preserved (Child-Pugh score ≤ 7, no encephalopathy) - You are in good enough overall health (ECOG ≤ 2, Karnofsky score ≥ 60) **You may NOT be eligible if...** - Your cancer has spread outside the liver (extrahepatic metastases or lymph node involvement) - You have severely impaired liver function or uncontrolled fluid buildup in the abdomen - You have a serious autoimmune disease or other condition that makes immunotherapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDownstaging procedures containing immunotherapy

Anti-PD-1 inhibitor will be given every 3-4 weeks intravenously according to the manufacturer's instruction. Other combination regimens, such as locoregional therapies or targeted therapies will be given to patients according to the protocol decided by the multidisciplinary team of Centers.

PROCEDURELiver transplantation

Patients with successful downstaging therapy at the end of the observation phase will enroll and undergo liver transplantation unless major medical or oncological contraindications should occur during the waiting phase.


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05475613


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