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.

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: adjuvant transarterial chemoinfusion (TAI); Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Study type: Interventional

Funder types: Other

Identifiers

NCT03192618

B2017-006-01

Details and patient eligibility

About

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

Enrollment: 290 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

treatment group

Experimental group

Treatment:

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

Procedure: adjuvant transarterial chemoinfusion (TAI)

control group

No Intervention group