Status and phase
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About
This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).
Full description
Primary Outcome Measures:
To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.
Secondary Outcome Measures:
To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.
Exploratory Outcome Measures:
To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.
Enrollment
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Inclusion criteria
Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
168 participants in 2 patient groups
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Central trial contact
Yehua Shen, MD, Ph D
Data sourced from clinicaltrials.gov
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