A Phase 3 interventional study of TACE and EGM in Carcinoma, Hepatocellular, sponsored by Nanjing Medical University. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Nanjing Medical University · Phase 3, Interventional, and Treatment
Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.
Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).
The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 236 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Occlude APS with EGM and perform TACE sequentially
Procedure: TACE · Drug: EGM
Occlude APS with PVA and perform TACE sequentially
Procedure: TACE · Drug: PVA
Transarterial chemoembolisation (TACE)
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
Occlude arterioportal shunts(APS) with PVA
overall survival
Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
Time frame: 3 years
APS improvement
Changes of Arterioportal Shunts Treated with PVA or EGM
Time frame: 2 month
Time To Progression
Time from randomization to radiological progression. Definition of progression is based on the mRECIST criteria. Deaths during follow-up without evidence of radiological progression are censored.
Time frame: every 8 weeks, upto 3 years from date of randomization
progression free survival
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.
Time frame: every 8 weeks, upto 3 years from date of randomization
Response Rate
Definition of response is based on the mRECIST criteria.
Time frame: every 8 weeks, upto 3 years from date of randomization
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Nanjing Medical University