Currently, there is no standard second line treatment for patients with neuroendocrine carcinoma. Irinotecan monotherapy or combination regimen has shown promising in previous study. The study was designed to confirm thet FOLFIRI regimen can be used as a second-line regimen for patients with advanced or metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with platinum based regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Irinotecan:180mg/m2 ,iv drip for 90min d1, 5-FU 2400mg/m2, iv drip for 46h, 5-FU 400mg/m2 iv d1, CF 200mg/m2 iv drip for 2h d1, q2W
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall response rate (ORR)
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation by RECIST 1.1
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival
Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Overall survival
Overall survival is defined as the time from date of start of treatment to date of death due to any cause
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Incidence of Treatment-related Adverse Events (Safety and Tolerability)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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