Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil
NCT ID: NCT02987699
Last Updated: 2016-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2016-11-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Full Dosage
Full Dosage Chemotherapy regimen administered by HAI
5-Fu, oxaliplatin , leucovorin
Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
Low Dosage of 5-Fu
Low Dose of 5-Fu Chemotherapy regimen administered by HAI
5-Fu, oxaliplatin , leucovorin
Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
Low Dosage of oxaliplatin
Low Dose of oxaliplatin Chemotherapy regimen administered by HAI
5-Fu, oxaliplatin , leucovorin
Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2
Interventions
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5-Fu, oxaliplatin , leucovorin
Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
5-Fu, oxaliplatin , leucovorin
Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
5-Fu, oxaliplatin , leucovorin
Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
diagnosed with major or main portal vein invasion (Vp3 or Vp4) KPS≥70； with no previous treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
The following laboratory parameters:
Platelet count ≥ 75,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug Serious non-healing wound, ulcer, or bone fracture Known central nervous system tumors including metastatic brain disease
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Shi Ming
Professor
Principal Investigators
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Ming Shi, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Department of Hepatobiliary Pancreatic Oncology of Sun Yat-sen University Cancer Center
Locations
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Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ming Shi, MD.
Role: primary
References
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Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
Other Identifiers
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Unique Protocol ID: HCC-S026
Identifier Type: -
Identifier Source: org_study_id