OncoMatch/Clinical Trials/NCT05475613
Downstaging Protocol Containing Immunotherapy for HCC Beyond the Milan Criteria Before Liver Transplantation
Is NCT05475613 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for liver transplantation.
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
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BEYOND MILAN CRITERIA, BARCELONA CLINIC LIVER CANCER B-C, CHINA LIVER CANCER STAGE IIB-IIIA
Patients with HCC must be beyond Milan criteria without extrahepatic metastases or lymph node metastases
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immunotherapy
Exception: immunotherapy within 6 months before enrollment
Have not received any immunotherapies 6 months before enrollment
Cannot have received:
Exception: recurrent liver cancer with inadequate initial treatment (i.e., no complete remission or R0 resection)
Recurrent liver cancer with inadequate initial treatment (i.e., no complete remission or R0 resection)
Lab requirements
Blood counts
Adequate bone marrow function required; ANC < 1.5 × 10⁹/L or platelet count < 50 × 10⁹/L excluded
Kidney function
Adequate renal function required
Liver function
Child-Pugh score ≤7, with no encephalopathy. Ascites that diuretics can control are permitted.
Child-Pugh score≤7, with no encephalopathy. Ascites that diuretics can control are permitted in this study. Adequate bone marrow, liver, and renal function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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