A Phase 4 interventional study of Chemoembolization and Response-Dependent Resection and Immediate Resection in Resectable Hepatocellular Carcinoma Beyond Milan Criteria, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-02.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the survival outcomes between hepatic resection and transarterial lipiodol chemoembolization (TACE) used as the initial treatment in patients with Resectable Hepatocellular Carcinoma Beyond Milan Criteria.
For patients with large/multiple, and resectable hepatocellular carcinomas (HCCs) without macrovascular invasion or extrahepatic spread, the choice of treatment remains largely controversial. For these patients, transarterial lipiodol chemoembolization (TACE) is recommended as a palliative therapy.
On the other hand, many authors still believe that hepatic resection is the only potential curative treatment in these patients because it is still feasible to remove all macroscopic tumors safely at surgery. With advances in surgical techniques, more large/multiple HCCs are now resectable, and long-term results have been reported that ranged from 30% to 58% at 5 years; even patients with large bilobar multiple HCC could reach a survival rate of more than 20% at 5 years after hepatic resection.
Until now, there have been only a few studies that compared the outcomes of hepatic resection and TACE in the treatment of multiple HCCs, and these have reported controversial results. Some studies showed that hepatic resection had survival benefi t over TACE, but other studies showed the opposite result ( 11-15 ). Therefore, the investigators performed this prospective study in consecutive patients with large/multiple, and resectable HCCs to compare the outcomes in patients who underwent hepatic resection or TACE as the initial treatment.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 436 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
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The following laboratory parameters:
Exclusion Criteria:
patients received immediate surgical hepatic resection
Procedure: Immediate Resection
patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.
Procedure: Chemoembolization and Response-Dependent Resection
patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.
patients received immediate surgical resection.
overall survival time
Time frame: 5 years
disease free survival
Time frame: 5 years
Number of Adverse Events
All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.
Time frame: 30 days
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University