A Phase 3 interventional study of Hepatic arterial infusion chemotherapy and Transarterial chemoembolization in HepatoCellular Carcinoma, sponsored by Sun Yat-sen University. Completed at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large hepatocellular carcinoma staged BCLC A/B.
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those with tumor larger than 10 cm. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 315 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Procedure: Hepatic arterial infusion chemotherapy · Drug: Folfox Protocol
Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
Procedure: Transarterial chemoembolization · Drug: TACE Drug Protocol
A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially.
Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.
oxaliplatin,leucovorin and 5-FU
Also known as: Folfox for TAI
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)
Also known as: Drugs for transarterial chemotherapy and embolization
Overall survival
Time frame: 24 months
Time to progression
Time frame: 24 months
Adverse Events
Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 Days after HAIC
Number of of Patients developed Adverse Events
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
Time frame: 30 Days after HAIC
Plan to share: Undecided
Ran from Oct 2016 to primary completion in Nov 2020, 49 months.
Of 83 non-industry phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 109. This study's 49 months is below that.
Counting every sponsor, half of 130 studies reached it within 57 months; a quarter within 44 and three quarters within 83.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folfox protocol