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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.

NCT ID: NCT02987907

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HepatoCellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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treatment group

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

control group

use normal saline 2ml I.A. during TACE

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

use normal saline 2ml I.A. during TACE

Interventions

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Dexamethasone

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

Intervention Type DRUG

Normal Saline

use normal saline 2ml I.A. during TACE

Intervention Type DRUG

Eligibility Criteria

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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;
* unrolled by other clinical trials about hepatocellular carcinoma.

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Shaohua

Attending Doctor, Department of Hepatobiliary Pancreatic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shaohua Li, MD

Role: CONTACT

Phone: +8615088064187

Email: [email protected]

Facility Contacts

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Shaohua Li, MD

Role: primary

Other Identifiers

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B2016-024-01

Identifier Type: -

Identifier Source: org_study_id