A retrospective clinical trial to study the safety and effectiveness of hepatic arterial infusion (HAI) in treating patients who have nasopharyngeal carcinoma metastatic to the liver. Hepatic-direction drug administration improves the control power for intra-hapatic lesions.
OBJECTIVES: I. Determine the safety and toxicity of hepatic arterial infusion with gemcitabine, floxuridine and dexamethasone in combination with standard treatment (radiotherapy and systemic chemotherapy) in patients with nasopharyngeal carcinoma metastases to liver. II. Determine the objective response of intrahepatic lesions of patients treated with this regimen. III. Determine the median survival time or overall survival time in patients treated with this regimen. OUTLINE: This is a single-center retrospective study. Patients receive DSA-guided implantation of HAI catheter system. HAI is initiated the next day. Gemcitabine intra-arterially for 30 minutes on day 1,8, floxuridine, dexamethasone intra-arterially continuously on days 1-14. Treatment repeats every 3 weeks in the absence of serious technical catheter-related problems, progression of intrahepatic lesions or unacceptable toxicity. Standard treatment of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) was performed as desired. Patients are followed every 2 HAI cycles or when necessary.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Implant the infusion catheter and injection port (Celsite, B. Braun, Chasseneuil, France) under DSA-guiding. The proximal end of the infusion catheter was connected to the injection port and the device was implanted in a subcutaneous pocket in the right inner thigh; the distal end of the infusion catheter guarantee uni-direction infusion to liver.
Given intra-arterially for 30 minutes
Given intra-arterially continuously for 14 days
Disease control rate (DCR) of intrahepatic lesions
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria.
Time frame: 2 years
Overall survival time
From the date of HAI catheter implantation to the date of death from any cause or to completion of trial, whichever comes first, up to 84 months.
Time frame: 7 years
Side effects and adverse events
To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Given intra-arterially continuously with 5-FUDR