Back to resultsThe Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TAI
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- older than 18 years old and younger than 75 years;
- ECOG PS≤1;
- proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;
- 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 surgery;
- distant metastasis exits;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- 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
- SUN YAT-SEN University Cancer CenterRecruiting
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
OS
overall survival
Secondary Outcome Measures
RFS
recurrence-free survival
recurrence rate
recurrence rate
PFS
progression free survival
Full Information
NCT ID
NCT03851913
First Posted
February 21, 2019
Last Updated
November 25, 2019
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03851913
Brief Title
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy
Official Title
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy: A Random, Controlled, Stage III Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
344 (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
Procedure
Intervention Name(s)
TAI
Intervention Description
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Primary Outcome Measure Information:
Title
OS
Description
overall survival
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
No
Eligibility Criteria
Inclusion Criteria:
older than 18 years old and younger than 75 years;
ECOG PS≤1;
proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
not previous treated for tumor;
the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;
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 surgery;
distant metastasis exits;
known history of other malignancy;
be allergic to related drugs;
underwent organ transplantation before;
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
Shaohua Li, MD
Phone
+8615088064187
Email
lishaoh@sysucc.org.cn
Facility Information:
Facility Name
SUN YAT-SEN University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong-Ping Guo, M.D.
Phone
00862087342266
Email
guorp@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Wei Wei, Ph.D. M.D.
Phone
00862087343790
Email
weiwei@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy
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