Clinical trial NCT04595864: Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
Official title: Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Liver Transplantation
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: RFS
timeFrame: From date of randomization until the date of recurrence, assessed up to 60 months
measure: recurrence rate
timeFrame: 1 year, 2 year, 3 year, 5 year after surgery
measure: PFS
timeFrame: From date of randomization until the date of progression, assessed up to 60 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum tower hospital
state: Jiangsu
Study officials:
affiliation: Nanjing University
name: Beicheng Sun, PhD，MD
role: STUDY_CHAIR
References: