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.

NCT02987907 | Unknown Phase 3 DMC

• 1 other identifier: B2016-024-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

HepatoCellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• response rate (RR)

  1 month after TACE

• proportions of participants with severe adverse events according to CTCAE v4.03

  1 month after TACE

Secondary Outcomes (3)

• 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

Study Arms (2)

treatment group

EXPERIMENTAL

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

Drug: Dexamethasone

control group

PLACEBO COMPARATOR

use normal saline 2ml I.A. during TACE

Drug: Normal Saline

Interventions

Dexamethasone DRUG

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

treatment group

Normal Saline DRUG

use normal saline 2ml I.A. during TACE

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, +86-20, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Shaohua Li, MD

CONTACT

+8615088064187; lishaoh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor, Department of Hepatobiliary Pancreatic Surgery

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 9, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 9, 2016

Record last verified: 2016-12

Locations

CN (1)