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.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    162
  • sponsor
    Sun Yat-sen University
Updated on 21 January 2021
thrombosis
fluorouracil
neutrophil count
TACE
chemoembolization
hepatectomy
tumor thrombosis

Summary

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

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment TACE, mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU), TAI, epidoxorubicin and cisplatin and lipiodol
Clinical Study IdentifierNCT03192644
SponsorSun Yat-sen University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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 count1.5109/L; hemoglobin80g/L; platelet count60109/L; serum albumin28g/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; PTupper limit of normal plus 6 seconds; INR2.3
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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
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