The study will be conducted to compare the safety and efficacy of irinotecan combined with cisplatin (IP regimen) and etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma. In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety for irinotecan combined with cisplatin (IP regimen) versus etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Irinotecan:60mg/m2 ,iv drip for 90min,d1,8 q3W cisplatin: 60mg/m2 ,iv drip for 120min,d1 q3W
Etoposide:100mg/m2 ,iv drip for 60min,d1-3 q3W cisplatin: 75mg/m2 ,iv drip for 120min,d1 q3W
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Overall response rate (ORR)
CT/MRI will be performed every 2 cycles of treatment 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-Emergent 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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