HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
NCT02856126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214
Last updated 2024-07-23
Summary
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).
Conditions
Interventions
- PROCEDURE
-
Hepatic arterial infusion chemotherapy
- PROCEDURE
-
Transarterial chemoembolization
- DRUG
-
TACE regimen
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
- DRUG
-
HAIC Regimen
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
- DRUG
-
Oral Sorafenib
Oral Sorafenib, 400mg, Bid
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Ming Shi, MD · The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2020-10-31
- Completion
- 2024-07-31
Countries
- China
Study Locations
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