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Clinical Trials in China / NCT03368651
Recruiting Phase 3

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.

NCT03368651 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 3
Started
2016-01-01
Last updated
2017-12-11

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

TAI

TAI: transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Center of Sun Yat-Sen University Guangzhou Guangdong Recruiting

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03368651 on ClinicalTrials.gov ↗ ← All trials in China