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RECRUITING
NCT04595864
PHASE3

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

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-11-01

Completion Date

2026-10-30

Last Updated

2021-11-05

Healthy Volunteers

No

Interventions

OTHER

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

TAI

Locations (1)

Nanjing Drum tower hospital

Nanjing, Jiangsu, China