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.

Who is this study for? Patients with Hepatocellular Carcinoma
What treatments are being studied? Transarterial Chemoinfusion
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Cancer Center of Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Shaohua Li, MD
lishaoh@sysucc.org.cn
+8615088064187
Time Frame
Start Date: 2016-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 230
Treatments
Experimental: treatment group
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
No_intervention: control group
no neo-adjuvant treatment before operation
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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