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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TAI

Study type: Interventional

Funder types: Other

Identifiers

NCT03851913

B2018-165-01

Details and patient eligibility

About

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

Enrollment: 344 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≤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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

treatment group

Experimental group

Description:

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

Treatment:

Procedure: TAI

control group

No Intervention group

Description:

no neo-adjuvant treatment before operation