Back to resultsThe Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
adjuvant transarterial chemoinfusion (TAI)
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
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<3;
- proven hepatocellular carcinoma with MVI according pathological examination;
- not previous treated for tumor;
- tumor was removed in operation;
- no recurrence occurence at 4 to 7 weeks after surgery;
- the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
- sign up consent;
- unrolled by other clinical trials about hepatocellular carcinoma.
Exclusion Criteria:
- cannot tolerate TAI;
- CNS or bone 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 hemorreage or cardiac/brain vascular events within 30 days;
- pregnancy;
Sites / Locations
- Cancer Center of Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment group
control group
Arm Description
Outcomes
Primary Outcome Measures
Disease-free survival (DFS)
disease-free survival
Secondary Outcome Measures
recurrence rate
recurrence rate
Overall survival (OS)
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03192618
Brief Title
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Official Title
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
adjuvant transarterial chemoinfusion (TAI)
Intervention Description
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Intervention Description
oxaliplatin, calcium folinate, and 5-FU
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
disease-free survival
Time Frame
From date of randomization until the date of recurrence, assessed up to 60 months
Secondary Outcome Measure Information:
Title
recurrence rate
Description
recurrence rate
Time Frame
1 year, 2 year, 3 year, 5 year after surgery
Title
Overall survival (OS)
Description
overall survival
Time Frame
From date of randomization until the date of death from any cause, 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<3;
proven hepatocellular carcinoma with MVI according pathological examination;
not previous treated for tumor;
tumor was removed in operation;
no recurrence occurence at 4 to 7 weeks after surgery;
the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
sign up consent;
unrolled by other clinical trials about hepatocellular carcinoma.
Exclusion Criteria:
cannot tolerate TAI;
CNS or bone 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 hemorreage 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
Cancer Center of Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
+86
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohua Li, MD
Phone
+8615088064187
Email
lishaoh@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32418078
Citation
Li S, Mei J, Wang Q, Guo Z, Lu L, Ling Y, Xu L, Chen M, Zheng L, Lin W, Zou J, Wen Y, Wei W, Guo R. Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial. Ann Surg Oncol. 2020 Dec;27(13):5183-5190. doi: 10.1245/s10434-020-08601-8. Epub 2020 May 16. Erratum In: Ann Surg Oncol. 2021 Dec;28(Suppl 3):874.
Results Reference
derived
Learn more about this trial
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
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