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, Contr

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Calcium; Calcium, Dietary; Cisplatin; Epirubicin; Ethiodized Oil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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;