The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2024-12-31

Brief Summary

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To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group

Group Type EXPERIMENTAL

adjuvant transarterial chemoinfusion (TAI)

Intervention Type PROCEDURE

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

mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Intervention Type DRUG

oxaliplatin, calcium folinate, and 5-FU

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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adjuvant transarterial chemoinfusion (TAI)

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

Intervention Type PROCEDURE

mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

oxaliplatin, calcium folinate, and 5-FU

Intervention Type DRUG

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 MVI according pathological examination;
* not previous treated for tumor;
* tumor was 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 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 hemorreage or cardiac/brain vascular events within 30 days;
* pregnancy;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No