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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595864
• Other study ID #: v1.0 20101014
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2020
• Est. completion date: October 30, 2026

Study information

• Verified date: October 2021
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Wenjie Zhang, PhD
• Phone: +86136221584216
• Email: drzhangwj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2026
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplantation

Intervention

Other:
• Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
TAI

Locations

Country	Name	City	State
China	Nanjing Drum tower hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	RFS	recurrence-free survival	From date of randomization until the date of recurrence, assessed up to 60 months
Secondary	recurrence rate	recurrence rate	1 year, 2 year, 3 year, 5 year after surgery
Secondary	PFS	progression free survival	From date of randomization until the date of progression, assessed up to 60 months