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.

Study Overview
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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.

Conditions
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HepatoCellular Carcinoma

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Normal Saline


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>use dexamethasone 10mg (2ml) I.A. during TACE | Drug: Dexamethasone<br>* use dexamethasone 10mg (2ml) I.A. during TACE<br>|
| Placebo Comparator: control group<br>use normal saline 2ml I.A. during TACE | Drug: Normal Saline<br>* use normal saline 2ml I.A. during TACE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate (RR) |  | 1 month after TACE | 
| proportions of participants with severe adverse events according to CTCAE v4.03 |  | 1 month after TACE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | From date of randomization until the date of death from any cause, assessed up to 60 months | 
| 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 | 
| 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 |