A Phase 3 interventional study of Hepatic arterial infusion chemotherapy and Transarterial chemoembolization in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Completed at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
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 BCLC stage hepatocellular carcinoma (HCC).
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 214 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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The following laboratory parameters:
Exclusion Criteria:
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
Procedure: Hepatic arterial infusion chemotherapy · Drug: HAIC Regimen · Drug: Oral Sorafenib
Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
Procedure: Transarterial chemoembolization · Drug: TACE regimen · Drug: Oral Sorafenib
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Oral Sorafenib, 400mg, Bid
Overall survival
Overall survival
Time frame: 18 months
Progress free survival
Progress free survival
Time frame: 18 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
Time frame: 30 Days
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University