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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.

Primary Purpose

HepatoCellular Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Normal Saline
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HepatoCellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Cancer Center of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment group

control group

Arm Description

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

use normal saline 2ml I.A. during TACE

Outcomes

Primary Outcome Measures

response rate (RR)
proportions of participants with severe adverse events according to CTCAE v4.03

Secondary Outcome Measures

overall survival (OS)
progression-free survival (PFS)
time to progression (TTP)

Full Information

First Posted
December 1, 2016
Last Updated
December 8, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02987907
Brief Title
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HepatoCellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
use dexamethasone 10mg (2ml) I.A. during TACE
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
use normal saline 2ml I.A. during TACE
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
use dexamethasone 10mg (2ml) I.A. during TACE
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
use normal saline 2ml I.A. during TACE
Primary Outcome Measure Information:
Title
response rate (RR)
Time Frame
1 month after TACE
Title
proportions of participants with severe adverse events according to CTCAE v4.03
Time Frame
1 month after TACE
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
From date of randomization until the date of death from any cause, assessed up to 60 months
Title
progression-free survival (PFS)
Time Frame
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
Title
time to progression (TTP)
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaohua Li, MD
Phone
+8615088064187
Email
lishaoh@sysucc.org.cn
Facility Information:
Facility Name
Cancer Center of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
+86-20
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohua Li, MD
Phone
+8615088064187
Email
lishaoh@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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.

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