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the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03777475
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Rong-ping Guo, Sun Yat-sen University

Study Description
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Brief Summary:
evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: transarterial infusion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: low dose
low oxaliplatin (85mg/m2)
 Procedure: transarterial infusion
transarterial infusion
Active Comparator: high dose
high oxaliplatin (135mg/m2)
 Procedure: transarterial infusion
transarterial infusion


Outcome Measures
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Primary Outcome Measures :
  1. OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
    overall survival


Secondary Outcome Measures :
  1. ORR [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
    object response rate

  2. PFS [ Time Frame: From date of randomization until the date of progress from any cause, assessed up to 60 months ]
    progression-free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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:

  • cannot tolerate TAI or surgery;
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777475


Locations
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China, Guangdong
SUN YAT-SEN University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rong-Ping Guo, M.D.    00862087342266    guorp@sysucc.org.cn   
Contact: Wei Wei, Ph.D. M.D.    00862087343790    weiwei@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Responsible Party: Rong-ping Guo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03777475    
Other Study ID Numbers: B2017-005-01
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases