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The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

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ClinicalTrials.gov Identifier: NCT03192644
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

Brief Summary:
To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: TAI Procedure: TACE Drug: epidoxorubicin and cisplatin and lipiodol Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 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) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Group A (TAI) Procedure: TAI
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
oxaliplatin, calcium folinate, and 5-FU

Active Comparator: Group B (TACE) Procedure: TACE
transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol

Drug: epidoxorubicin and cisplatin and lipiodol
epidoxorubicin and cisplatin and lipiodol




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



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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 PVTT according pathological examination;
  • not previous treated for tumor;
  • tumor and tumor thrombosis were 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 TACE or 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 hemorrhage or cardiac/brain vascular events within 30 days;
  • pregnancy;

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): NCT03192644


Contacts
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Contact: Li Shaohua, MD +86 lishaoh@sysucc.org.cn

Locations
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China
Cancer Center of Sun Yat-Sen University Recruiting
Guangzhou, China
Contact: Shaohua Li, MD       lishaoh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Rong-ping Guo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03192644     History of Changes
Other Study ID Numbers: B2017-004-01
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: January 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
Thrombosis
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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium, Dietary
Leucovorin
Cisplatin
Oxaliplatin
Ethiodized Oil
Epirubicin
Calcium
Levoleucovorin
Antineoplastic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents