Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation

Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation

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.

Inclusion Criteria:

1. older than 18 years old and younger than 75 years listed for liver transplant;

2. ECOG PS≤1;

3. Child-Pugh Stage A or B

4. Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;

5. Not previous treated for tumor;

6. The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT

7. No distant metastasis;

8. The lab test could meet:

   Neutrophil count≥2.0×109/L; Hemoglobin≥100g/L; Platelet count≥75×109/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;

9. Sign up consent.

Exclusion Criteria:

1. Cannot tolerate TAI or LT;
2. Distant metastasis exits;
3. Known history of other malignancy;
4. Be allergic to related drugs;
5. Be treated before (interferon included);
6. Known history of HIV infection;
7. Known history of drug or alcohol abuse;
8. Have GI hemorrhage or cardiac/brain vascular events within 30 days;
9. Pregnancy.