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 University

Status and phase: Unknown; Phase 3

Conditions: HepatoCellular Carcinoma

Treatments: Drug: Dexamethasone; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02987907

B2016-024-01

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

treatment group

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

control group

Placebo Comparator group

Description:

use normal saline 2ml I.A. during TACE

Treatment:

Drug: Normal Saline