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NCT Number: NCT04595864

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nanjing Drum tower hospital

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Beicheng Sun, Phd,MD

CONTACT

[email protected]

+8613776413940

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • older than 18 years old and younger than 75 years listed for liver transplant;
  • ECOG PS≤1;
  • Child-Pugh Stage A or B
  • Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
  • Not previous treated for tumor;
  • The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT
  • No distant metastasis;
  • 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;

  • Sign up consent.

Exclusion criteria

  • Cannot tolerate TAI or LT;
  • Distant metastasis exits;
  • Known history of other malignancy;
  • Be allergic to related drugs;
  • Be treated before (interferon included);
  • Known history of HIV infection;
  • Known history of drug or alcohol abuse;
  • Have GI hemorrhage or cardiac/brain vascular events within 30 days;
  • Pregnancy.

Treatment and study plan

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

Other

TAI

Other names: TAI

Primary outcomes

  1. OS

    Time frame: 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 outcomes

  1. RFS

    Time frame: From date of randomization until the date of recurrence, assessed up to 60 months

    recurrence-free survival

  2. recurrence rate

    Time frame: 1 year, 2 year, 3 year, 5 year after surgery

    recurrence rate

  3. PFS

    Time frame: From date of randomization until the date of progression, assessed up to 60 months

    progression free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjie Zhang, PhD

CONTACT

[email protected]

+86136221584216

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Oct 22, 2020
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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