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.

HepatoCellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02987907
• Other study ID #: B2016-024-01
• Status: Recruiting
• Phase: Phase 3
• First received: December 1, 2016
• Last updated: December 8, 2016
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: December 2016
• Source: Sun Yat-sen University
• Contact: Shaohua Li, MD
• Phone: +8615088064187
• Email: lishaoh[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: IRB of Cancer Center of Sun Yat-Sen University: China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma

Intervention

Drug:
• Dexamethasone
use dexamethasone 10mg (2ml) I.A. during TACE
• Normal Saline
use normal saline 2ml I.A. during TACE

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate (RR)		1 month after TACE	No
Primary	proportions of participants with severe adverse events according to CTCAE v4.03		1 month after TACE	Yes
Secondary	overall survival (OS)		From date of randomization until the date of death from any cause, assessed up to 60 months	No
Secondary	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	No
Secondary	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	No