OncoMatch/Clinical Trials/NCT04595864
Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
Is NCT04595864 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. Milan (solitary tumour \<5cm, or up to 3 tumours, each \<3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none \>4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of \>70% and recurrence rate ranging from 5-15% can be achieved. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria，and qualify for LT. This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any prior treatment (including interferon)
Not previous treated for tumor; Be treated before (interferon included)
Lab requirements
Blood counts
Neutrophil count ≥2.0×10^9/L; Hemoglobin ≥100g/L; Platelet count ≥75×10^9/L
Kidney function
Serum creatine <1.5x ULN
Liver function
Child-Pugh Stage A or B; Total bilirubin <2x ULN; ALT <3x ULN; AST <3x ULN; Serum albumin ≥35g/L; PT ≤ ULN + 4s; INR ≤2.2
The lab test could meet: Neutrophil count≥2.0×10^9/L; Hemoglobin≥100g/L; Platelet count≥75×10^9/L; Serum albumin≥35g/L; Total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; Serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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