The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TAI

• Registration Number: NCT03851913
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-29
• Primary Completion: 2022-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• older than 18 years old and younger than 75 years;

• ECOG PS≤1;

• proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;

• not previous treated for tumor;

• the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;

• no distant metastasis;

• the lab test could meet:

  • neutrophil count≥2.0×109/L;
  • hemoglobin≥100g/L;
  • platelet count≥75×109/L;
  • serum albumin≥35g/L;
  • total bilirubin<2-times upper limit of normal;
  • ALT<3-times upper limit of normal;
  • AST<3-times upper limit of normal;
  • serum creatine<1.5-times upper limit of normal;
  • PT≤upper limit of normal plus 4 seconds;
  • INR≤2.2;

• sign up consent.

Exclusion Criteria

• cannot tolerate TAI or surgery;
• distant 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
OS	From date of randomization until the date of death from any cause, assessed up to 60 months	overall survival

Secondary Outcome Measures

Name	Time	Method
RFS	From date of randomization until the date of recurrence, assessed up to 60 months	recurrence-free survival
recurrence rate	1 year, 2 year, 3 year, 5 year after surgery	recurrence rate
PFS	From date of randomization until the date of progression, assessed up to 60 months	progression free survival

Trial Locations

Locations (1)

SUN YAT-SEN University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China