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
NCT ID: NCT03851913
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
344 participants
INTERVENTIONAL
2018-07-01
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
TAI
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
control group
no neo-adjuvant treatment before operation
No interventions assigned to this group
Interventions
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TAI
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Rong-ping Guo
Professor
Locations
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SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Rong-Ping Guo, M.D.
Role: primary
Wei Wei, Ph.D. M.D.
Role: backup
Other Identifiers
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B2018-165-01
Identifier Type: -
Identifier Source: org_study_id