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.
1 other identifier
interventional
162
1 country
1
Brief Summary
To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hepatocellular-carcinoma
Started Jul 2017
Longer than P75 for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 20, 2017
January 1, 2017
5.5 years
June 16, 2017
June 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
recurrence-free survival (RFS)
recurrence-free survival
From date of randomization until the date of recurrence, assessed up to 60 months
Secondary Outcomes (2)
recurrence rate
1 year, 2 year, 3 year, 5 year after surgery
Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to 60 months
Study Arms (2)
Group A (TAI)
EXPERIMENTALGroup B (TACE)
ACTIVE COMPARATORInterventions
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol
epidoxorubicin and cisplatin and lipiodol
oxaliplatin, calcium folinate, and 5-FU
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Center of Sun Yat-Sen University
Guangzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2017
First Posted
June 20, 2017
Study Start
July 1, 2017
Primary Completion
December 31, 2022
Study Completion
December 31, 2024
Last Updated
June 20, 2017
Record last verified: 2017-01