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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.

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.

Non Recruiting
18-75 years
All
Phase 3

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Overview

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

Eligibility

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; platelet count≥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; serum creatine<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 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 details
    Hepatocellular Carcinoma

NCT03192644

Sun Yat-sen University

20 August 2025

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