HAIC of FOLFOX Plus Sorafenib vs HAIC of FOLFIRINOX Plus Sorafenib for Advcanced HCC
NCT ID: NCT03812783
Last Updated: 2019-01-23
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
100 participants
INTERVENTIONAL
2018-11-05
2019-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HAIC of FOLFIRINOX plus sorafenib
Sorafenib
administration of Sorafenib
Hepatic arterial infusion chemotherapy
administration of Irinotecan, Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
FOLFIRINOX
Irinotecan, Oxaliplatin , fluorouracil, and leucovorin
HAIC of FOLFOX plus sorafenib
Hepatic arterial infusion chemotherapy
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Folfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
Sorafenib
administration of Sorafenib
Interventions
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Hepatic arterial infusion chemotherapy
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Folfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
Sorafenib
administration of Sorafenib
Hepatic arterial infusion chemotherapy
administration of Irinotecan, Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
FOLFIRINOX
Irinotecan, Oxaliplatin , fluorouracil, and leucovorin
Eligibility Criteria
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Inclusion Criteria
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* 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
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* 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
Clinical Professor
Locations
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Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Facility Contacts
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Other Identifiers
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HCC-S053
Identifier Type: -
Identifier Source: org_study_id
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