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 (Jun 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)
Demographics
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.
Frequently asked questions
Is NCT04595864 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages