Back to results

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

Primary Purpose

Hepatocellular Carcinoma, Liver Transplantation

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nanjing Drum tower hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

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

no neo-adjuvant treatment before operation

Outcomes

Primary Outcome Measures

From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcome Measures

RFS

recurrence-free survival

recurrence rate

PFS

progression free survival

Full Information

NCT ID

NCT04595864

First Posted

October 13, 2020

Last Updated

October 28, 2021

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT04595864

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Liver Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

No Intervention

Arm Description

no neo-adjuvant treatment before operation

Intervention Type

Other

Intervention Name(s)

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

Other Intervention Name(s)

TAI

Intervention Description

TAI

Primary Outcome Measure Information:

Title

Description

From date of randomization until the date of death from any cause, assessed up to 60 months

Time Frame

From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcome Measure Information:

Title

RFS

Description

recurrence-free survival

Time Frame

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

Title

recurrence rate

Description

recurrence rate

Time Frame

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

Title

PFS

Description

progression free survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenjie Zhang, PhD

Phone

+86136221584216

drzhangwj@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beicheng Sun, PhD，MD

Organizational Affiliation

Nanjing University

Official's Role

Study Chair

Facility Information:

Facility Name

Nanjing Drum tower hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beicheng Sun, Phd,MD

Phone

+8613776413940

sunbc@nju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs