The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Last updated: June 19, 2017
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Thrombosis

Liver Disorders

Liver Disease

Treatment

N/A

Clinical Study ID

NCT03192644
B2017-004-01
  • Ages 18-75
  • All Genders

Study Summary

To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • ECOG PS<3;

  • proven hepatocellular carcinoma with PVTT according pathological examination;

  • not previous treated for tumor;

  • tumor and tumor thrombosis were 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; plateletcount≥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; serumcreatine<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

Exclusion Criteria:

  • cannot tolerate TACE or 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 hemorrhage or cardiac/brain vascular events within 30 days;

  • pregnancy;

Study Design

Total Participants: 162
Study Start date:
July 01, 2017
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Cancer Center of Sun Yat-Sen University

    Guangzhou,
    China

    Active - Recruiting

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