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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanjing Drum tower hospital
RECRUITING
Nanjing
Contact Information
Primary
Wenjie Zhang, PhD
drzhangwj@163.com
+86136221584216
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 40
Treatments
Experimental: treatment group
Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
No_intervention: control group
no neo-adjuvant treatment before operation
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov