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The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03851913
Collaborator
(none)
344
Enrollment
1
Location
2
Arms
74
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TAI
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
344 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy: A Random, Controlled, Stage III Clinical Trial
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment group

transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Procedure: TAI
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
No Intervention: control group

no neo-adjuvant treatment before operation

Outcome Measures

Primary Outcome Measures

  1. OS [From date of randomization until the date of death from any cause, assessed up to 60 months]

    overall survival

Secondary Outcome Measures

  1. RFS [From date of randomization until the date of recurrence, assessed up to 60 months]

    recurrence-free survival

  2. recurrence rate [1 year, 2 year, 3 year, 5 year after surgery]

    recurrence rate

  3. PFS [From date of randomization until the date of progression, assessed up to 60 months]

    progression free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  • the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;

  • no distant metastasis;

  • 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;

  • distant 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 SUN YAT-SEN University Cancer Center Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rong-ping Guo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03851913
Other Study ID Numbers:
  • B2018-165-01
First Posted:
Feb 22, 2019
Last Update Posted:
Nov 29, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Nov 29, 2019