HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC
NCT03803254 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2019-05-06
Summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)
Conditions
Interventions
- PROCEDURE
-
Hepatic arterial infusion chemotherapy
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
- DRUG
-
Folfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
- DRUG
-
12 mg (or 8 mg) once daily (QD) oral dosing.
- DRUG
-
PD-1 antibody
3mg/kg intravenously every 2 weeks
Sponsors & Collaborators
-
Kaiping Central Hospital
collaborator OTHER -
Guangzhou No.12 People's Hospital
collaborator OTHER_GOV -
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Ming Shi, MD · Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-03
- Primary Completion
- 2021-01-01
- Completion
- 2021-01-01
Countries
- China
Study Locations
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