The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

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Sun Yat-sen University

Status and phase

Enrolling
Phase 3

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: TAI

Study type

Interventional

Funder types

Other

Identifiers

NCT03368651
B2017-076-01

Details and patient eligibility

About

To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.

Enrollment

230 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;
  • estimated tumor and tumor thrombosis could be removed en bloc in operation;
  • 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

Parallel Assignment

Masking

None (Open label)

230 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

Trial contacts and locations

0

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Central trial contact

Shaohua Li, MD

Data sourced from clinicaltrials.gov

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