Efficacy of Combine Dexamethasone and N-Acetylcysteine for prevent Post-embolization syndrome after Transarterial Chemoembolization in hepatocellular carcinoma (HCC) ,A double-blind, Randomized controlled trial

Efficacy of Combine Dexamethasone and N-Acetylcysteine for prevent Post-embolization syndrome after Transarterial Chemoembolization in hepatocellular carcinoma (HCC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220412008

Enrollment

Registered

2022-04-12

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To evaluate efficacy of Dexamethasone plus N-Acetylcysteine for prevention to develop Postembolization syndrome and Liver decompensation after TACE Hepatocellular carcinoma , post embolization syndrome , TACE , Transarterial Chemoembolization , Dexamethasone , N-Acetylcysteine , Liver Decompensation

Interventions

The Dexa plus NAC group received intravenous dexamethasone 10 mg v q 12 hr plus NAC 24 h prior to TACE (150 mg/ kg/h for 1 h followed by 12.5 mg/kg/h for 4 h, then continuous infusion 6.25 mg/h plu

Experimental Drug,Active Comparator Drug

Dexamethasone and N-Acetylcysteine,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eligible individuals were inpatients aged between 18 to 80 years with diagnosed early or intermediate state HCC base on Barcelona Clinical Liver Cancer (BCLC) without main portal vein invasion and extrahepatic metastasis and fit ( ECOG 0-1) for underwent TACE treatment. Criteria diagnosis of HCC was presence of histologically confirmed or radiologically diagnosed HCC (fulfilled criteria for lesions with typical imaging according to American Association for the study of Liver Disease (ASLD) Europian Association for the study of Liver (EASL) or Thai Association for the study of Liver (THASL).

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follow 1.Decompensated Liver cirrhosis (child Pugh score more than 9) 2. congestive heart failure and/or respiratory failure 3. severe comorbid illness with expected life expectancy < 6 months ( e.g. end stage renal disease , poor control DM or HbA1C > 8.5, Uncontrolled HT (SBP > 180 mmHg or DBP > 120 mmHg) 4. severe allergy or anaphylaxis/anaphylactoid to NAC or Drug interaction with nitroglycerine 5. pregnancy 6. History using of NSAID, Steroid, NAC with 21 days 7. Main portal vein invasion 8. refusal to participated in this study

Design outcomes

Primary

Measure	Time frame
development of post-embolization syndrome 6 weeks Post-embolization syndrome , Defined base on base on South west oncology group (SWOG) toxic coding more than 2 point	—

Secondary

Measure	Time frame
Development of post-TACE liver decompensation and duration of admission between to group 6 weeks Development of post-TACE liver decompensation define as 1. TB rising more than 2 2.new onset Ascite 3.new HE 4.CPS score rising more than 2 and duration of admission between admit to discharg	—

Countries

Thailand

Contacts

Public ContactNitipon Simasingha

Faculty of medicine , Navamintharadhiraj university

nitipon@nmu.ac.th0814009228

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026