Hepatic Artery Infusion Pump for NPC Liver Metastases
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|ClinicalTrials.gov Identifier: NCT03876574|
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma Neoplasm Metastasis Liver||Procedure: DSA-guided implantation of hepatic artery infusion pump Drug: Gemcitabine Drug: Floxuridine Drug: dexamethasone||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases|
|Actual Study Start Date :||January 1, 2011|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Patients undergo DSA-guided implantation of hepatic artery infusion pump. All patients receive the intervention "Hepatic artery infusion of gemcitabine and floxuridine" the next day after pump implantation. The HAI therapy is initiated on day 1, 8: Gemcitabine 1g/m2 for 30 minutes, followed by a blended solution which comprised floxuridine (FUDR) at 0.15 mg/kg/day, dexa-methasone (DXM) at 1 mg/m2/day, low molecular heparin 3200U and saline, lasted for 7 days continuously.Standard treatments of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) are performed as desired.
Procedure: DSA-guided implantation of hepatic artery infusion pump
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
Other Name: 5-FUDR
Given intra-arterially continuously with 5-FUDR
Other Name: DXM
- Disease control rate (DCR) of intrahepatic lesions [ Time Frame: 2 years ]Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria.
- Overall survival time [ Time Frame: 7 years ]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.
- Side effects and adverse events [ Time Frame: 2 years ]To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity