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

Official Title
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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.

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TAI
* Procedure: TACE
* Drug: epidoxorubicin and cisplatin and lipiodol
* Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (TAI)<br> | Procedure: TAI<br>* transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)<br>Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)<br>* oxaliplatin, calcium folinate, and 5-FU<br>|
| Active Comparator: Group B (TACE)<br> | Procedure: TACE<br>* transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol<br>Drug: epidoxorubicin and cisplatin and lipiodol<br>* epidoxorubicin and cisplatin and lipiodol<br>|

What is the study measuring?
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Primary Outcome Measures

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