Transarterial Chemoinfusion for Liver Transplant Candidates with Advanced Liver Cancer

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

This study is testing a new treatment called transarterial chemoinfusion to see if it can help people with advanced liver cancer qualify for a liver transplant.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT04595864 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of neo-adjuvant transarterial chemoinfusion (TAI) with mFOLFOX6 in patients with hepatocellular carcinoma (HCC) who do not meet the Milan/UCSF criteria for liver transplantation. The goal is to down-stage their tumors to qualify for transplantation, which is the most effective treatment for HCC. The study compares survival outcomes between patients receiving TAI and those who do not, aiming to improve eligibility for liver transplantation. Participants must be between 18 and 75 years old and have specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with hepatocellular carcinoma beyond Milan/UCSF criteria who are listed for liver transplantation.

Not a fit: Patients with distant metastasis, previous malignancies, or those who cannot tolerate TAI or liver transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the number of patients eligible for liver transplantation, improving survival rates for those with advanced HCC.

How similar studies have performed: While there have been studies on hepatic artery infusion chemotherapy, this specific approach for down-staging HCC beyond established criteria is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing Drum tower hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wenjie Zhang, PhD

Conditions Hepatocellular Carcinoma; Liver Transplantation