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.

Phase 3

• Conditions: HepatoCellular Carcinoma
• Interventions: Drug: Normal Saline; Drug: Dexamethasone

• Registration Number: NCT02987907
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Study First Posted: 2016-12-09
• Last Update Posted: 2016-12-09
• Primary Completion: 2019-07
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Normal Saline	use normal saline 2ml I.A. during TACE
treatment group	Dexamethasone	use dexamethasone 10mg (2ml) I.A. during TACE

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Center of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China