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.

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: adjuvant transarterial chemoinfusion (TAI); Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

• Registration Number: NCT03192618
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20
• Study Start: 2017-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	adjuvant transarterial chemoinfusion (TAI)	-
treatment group	mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	From date of randomization until the date of recurrence, assessed up to 60 months	disease-free survival

Secondary Outcome Measures

Name	Time	Method
recurrence rate	1 year, 2 year, 3 year, 5 year after surgery	recurrence rate
Overall survival (OS)	From date of randomization until the date of death from any cause, assessed up to 60 months	overall survival

Trial Locations

Locations (1)

Cancer Center of Sun Yat-Sen University; 🇨🇳 Guangzhou, China