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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192618
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Rong-ping Guo, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: adjuvant transarterial chemoinfusion (TAI) Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment group Procedure: adjuvant transarterial chemoinfusion (TAI)
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
oxaliplatin, calcium folinate, and 5-FU
No Intervention: control group


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: From date of randomization until the date of recurrence, assessed up to 60 months ]
    disease-free survival


Secondary Outcome Measures :
  1. recurrence rate [ Time Frame: 1 year, 2 year, 3 year, 5 year after surgery ]
    recurrence rate

  2. Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
    overall 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<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;
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): NCT03192618


Contacts
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Contact: Shaohua Li, MD +8615088064187 lishaoh@sysucc.org.cn

Locations
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China
Cancer Center of Sun Yat-Sen University Recruiting
Guangzhou, China, +86
Contact: Shaohua Li, MD    +8615088064187    lishaoh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rong-ping Guo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03192618    
Other Study ID Numbers: B2017-006-01
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
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
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
 Pathologic Processes
Leucovorin
Oxaliplatin
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients