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.

Recruiting now · Phase 3

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID: NCT03368651
Run by: Sun Yat-sen University
People needed: 230
Starts: 2016-01-01
Expected to finish: 2028-12-31
Last updated by the study team: 2017-12-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;

You may not qualify if…

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;

Where it is running

Cancer Center of Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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