the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
NCT ID: NCT03777475
Last Updated: 2018-12-17
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
NA
350 participants
INTERVENTIONAL
2016-07-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low dose
low oxaliplatin (85mg/m2)
transarterial infusion
transarterial infusion
high dose
high oxaliplatin (135mg/m2)
transarterial infusion
transarterial infusion
Interventions
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transarterial infusion
transarterial infusion
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;
* unresectable;
* 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
* 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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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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B2017-005-01
Identifier Type: -
Identifier Source: org_study_id