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.

June 19, 2017 updated by: Rong-ping Guo, Sun Yat-sen University
To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence-free survival (RFS)
Time Frame: From date of randomization until the date of recurrence, assessed up to 60 months
recurrence-free survival
From date of randomization until the date of recurrence, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: 1 year, 2 year, 3 year, 5 year after surgery
recurrence rate
1 year, 2 year, 3 year, 5 year after surgery
Overall survival (OS)
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival
From date of randomization until the date of death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (ACTUAL)

June 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2017-004-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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