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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.

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TAI
TACE
epidoxorubicin and cisplatin and lipiodol
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Cancer Center of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (TAI)

Group B (TACE)

Arm Description

Outcomes

Primary Outcome Measures

recurrence-free survival (RFS)
recurrence-free survival

Secondary Outcome Measures

recurrence rate
recurrence rate
Overall survival (OS)
overall survival

Full Information

First Posted
June 16, 2017
Last Updated
June 19, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03192644
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (TAI)
Arm Type
Experimental
Arm Title
Group B (TACE)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TAI
Intervention Description
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol
Intervention Type
Drug
Intervention Name(s)
epidoxorubicin and cisplatin and lipiodol
Intervention Description
epidoxorubicin and cisplatin and lipiodol
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Intervention Description
oxaliplatin, calcium folinate, and 5-FU
Primary Outcome Measure Information:
Title
recurrence-free survival (RFS)
Description
recurrence-free survival
Time Frame
From date of randomization until the date of recurrence, assessed up to 60 months
Secondary Outcome Measure Information:
Title
recurrence rate
Description
recurrence rate
Time Frame
1 year, 2 year, 3 year, 5 year after surgery
Title
Overall survival (OS)
Description
overall survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Shaohua, MD
Phone
+86
Email
lishaoh@sysucc.org.cn
Facility Information:
Facility Name
Cancer Center of Sun Yat-Sen University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohua Li, MD
Email
lishaoh@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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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