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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma, Liver Transplantation

Intervention / Treatment
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* Other: Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older than 18 years old and younger than 75 years listed for liver transplant; ECOG PS≤1; Child-Pugh Stage A or B Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; Not previous treated for tumor; The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT No distant metastasis; 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; Sign up consent. Exclusion Criteria: Cannot tolerate TAI or LT; Distant metastasis exits; Known history of other malignancy; Be allergic to related drugs; Be treated before (interferon included); Known history of HIV infection; Known history of drug or alcohol abuse; Have GI hemorrhage or cardiac/brain vascular events within 30 days; Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) | Other: Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)<br>* TAI<br>* Other names: TAI;|
| No Intervention: control group<br>no neo-adjuvant treatment before operation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | From date of randomization until the date of death from any cause, assessed up to 60 months | From date of randomization until the date of death from any cause, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFS | recurrence-free survival | From date of randomization until the date of recurrence, assessed up to 60 months | 
| recurrence rate | recurrence rate | 1 year, 2 year, 3 year, 5 year after surgery | 
| PFS | progression free survival | From date of randomization until the date of progression, assessed up to 60 months |