Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC
NCT ID: NCT03812770
Last Updated: 2019-04-17
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
150 participants
INTERVENTIONAL
2018-08-04
2019-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sorafenib plus HAIC of OXA
Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin
Sorafenib
Oral Sorafenib, 400mg, Bid
HAIC of OXA
administration of Oxaliplatin via the tumor feeding arteries
Sorafenib plus HAIC of FOLFOX
Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin
Sorafenib
Oral Sorafenib, 400mg, Bid
HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Interventions
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Sorafenib
Oral Sorafenib, 400mg, Bid
HAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
HAIC of OXA
administration of Oxaliplatin via the tumor feeding arteries
Other Intervention Names
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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.
* 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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Kaiping Central Hospital
OTHER
Guangzhou No.12 People's Hospital
OTHER_GOV
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
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China
Kaiping Central Hospital
Kaiping, Guangdong, China
Countries
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Facility Contacts
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Other Identifiers
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HCC-OXA
Identifier Type: -
Identifier Source: org_study_id
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