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

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma; Liver Transplantation
• Interventions: Other: Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

• Registration Number: NCT04595864
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2020-11-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05
• Primary Completion: 2024-11-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)	Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Nanjing Drum tower hospital; 🇨🇳 Nanjing, Jiangsu, China