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

NCT04595864 | Recruiting Phase 3

• 1 other identifier: v1.0 20101014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• RFS

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

• recurrence rate

  1 year, 2 year, 3 year, 5 year after surgery

• PFS

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

Study Arms (2)

treatment group

EXPERIMENTAL

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

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

control group

NO INTERVENTION

no neo-adjuvant treatment before operation

Interventions

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

TAI

Also known as: TAI

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum tower hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Beicheng Sun, PhD，MD

  Nanjing University

  STUDY CHAIR

Central Study Contacts

Wenjie Zhang, PhD

CONTACT

+86136221584216; drzhangwj@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hepatobiliary Surgery

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2024
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)