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.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    230
  • sponsor
    Sun Yat-sen University
Updated on 23 February 2022
thrombosis
calcium
metastasis
oxaliplatin
neutrophil count
hepatectomy
tumor thrombosis

Summary

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

Details
Condition Hepatocellular Carcinoma
Treatment TAI
Clinical Study IdentifierNCT03368651
SponsorSun Yat-sen University
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

older than 18 years old and younger than 75 years
ECOG PS1
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 count2.0109/L; hemoglobin100g/L; platelet count75109/L; serum albumin35g/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; PTupper limit of normal plus 4 seconds; INR2.2
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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
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