Clinical trial NCT03876574: Hepatic Artery Infusion Pump for NPC Liver Metastases
Official title: Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nasopharyngeal Carcinoma
Neoplasm Metastasis
Liver
Keywords: Hepatic artery infusion pump
Gemcitabine
Floxuridine
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed nasopharyngeal carcinoma with histologically confirmed or image diagnosed metastatic to the liver
* Standard treatment of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) is performed as desired
* Performance status - ECOG 0-2
* Absolute neutrophil count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)
* Creatinine no greater than ULN
* Creatinine clearance greater than 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate oral nutrition (at least 1,500 calories/day)
* Able to withstand major operative procedure
* No dehydration
* No severe anorexia
* No frequent nausea or vomiting
* No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
* No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis
* No concurrent immunotherapy
* No concurrent colony-stimulating factors during the first course of study therapy
* No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan
* No prior hepatic artery infusion therapy with 5-FU or floxuridine
* No prior systemic chemotherapy for metastatic disease
* No prior or concurrent sorivudine or brivudine

Primary outcomes:
measure: Disease control rate (DCR) of intrahepatic lesions
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival time
timeFrame: 7 years
measure: Side effects and adverse events
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
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