The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.

Sun Yat-sen University1 site in 1 country220 target enrollmentAugust 2016

ConditionsHepatoCellular Carcinoma

InterventionsDexamethasone Normal Saline

DrugsDexamethasone Normal Saline

Overview

Phase: Phase 3
Intervention: Dexamethasone
Conditions: HepatoCellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 220
Locations: 1
Primary Endpoint: response rate (RR)
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

August 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Li Shaohua

Attending Doctor, Department of Hepatobiliary Pancreatic Surgery

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•older than 18 years old;
•ECOG PS\<3;
•proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
•meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone
•not previous treated for tumor;
•Child-Pugh A or B;
•at least one measurable lesion according mRECIST;
•cannot afford sorafenib;
•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;

Exclusion Criteria

•cannot tolerate TACE;
•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 hemorrage or cardiac/brain vascular events within 30 days;
•pregnancy;

Arms & Interventions

treatment group

use dexamethasone 10mg (2ml) I.A. during TACE

Intervention: Dexamethasone

control group

use normal saline 2ml I.A. during TACE

Intervention: Normal Saline

Outcomes

Primary Outcomes

response rate (RR)

Time Frame: 1 month after TACE

proportions of participants with severe adverse events according to CTCAE v4.03

Time Frame: 1 month after TACE

Secondary Outcomes

progression-free survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
overall survival (OS)(From date of randomization until the date of death from any cause, assessed up to 60 months)
time to progression (TTP)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)