- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368651
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
December 8, 2017 updated by: Rong-ping Guo, Sun Yat-sen University
To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
230
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, +86
- Recruiting
- Cancer center of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- estimated tumor and tumor thrombosis could be removed en bloc in operation;
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
|
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
|
No Intervention: control group
no neo-adjuvant treatment before operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
|
overall survival
|
From date of randomization until the date of death from any cause, assessed up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence rate
Time Frame: 1 year, 2 year, 3 year, 5 year after surgery
|
recurrence rate
|
1 year, 2 year, 3 year, 5 year after surgery
|
recurrence-free survival (RFS)
Time Frame: From date of randomization until the date of recurrence, assessed up to 60 months
|
recurrence-free survival
|
From date of randomization until the date of recurrence, assessed up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Anticipated)
November 30, 2026
Study Completion (Anticipated)
December 31, 2028
Study Registration Dates
First Submitted
December 4, 2017
First Submitted That Met QC Criteria
December 8, 2017
First Posted (Actual)
December 11, 2017
Study Record Updates
Last Update Posted (Actual)
December 11, 2017
Last Update Submitted That Met QC Criteria
December 8, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Embolism and Thrombosis
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Thrombosis
Other Study ID Numbers
- B2017-076-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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