An interventional study of TACE-HAIC and HAIC in Potentially Resection and Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC.
EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 240 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion
Drug: TACE-HAIC
FOLFOX-based chemotherapy hepatic artery infusion
Drug: HAIC
transcatheter arterial chemo-lipiodolization with EADM 30mg/m2, followed by hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
progression-free survival
Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC
Time frame: 6-12 months
overall survival
time to death or last follow-up after random assignment to TACE-HAIC or HAIC
Time frame: 6-12 months
Downstage hepatectomy rate
The hepatectomy rate after TACE-HAIC or HAIC
Time frame: 6-12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University