Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated November 5, 2021 (before its estimated November 30, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-10-20.
Status change: Not Yet Recruiting → Recruiting 2021-10-28
Trial Details
NCT Number NCT04595864
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions Hepatocellular Carcinoma, Liver Transplantation
Enrollment 40 participants
Start Date 2020-11-01
Primary Completion 2024-11-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2021-11-05