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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.

RECRUITINGPhase 3Sponsored by Sun Yat-sen University
Actively Recruiting
PhasePhase 3
SponsorSun Yat-sen University
Started2016-01-01
Est. completion2026-11-30
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* 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 count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/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; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
* sign up consent;

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;

Conditions4

CancerHepatocellular CarcinomaLiver CancerLiver Disease

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