The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
The prognosis of gastrointestinal neuroendocrine tumor G3 type patients who cannot be surgically resected is poor. The median overall survival (OS) is only 6-10 months, and the 3-year survival rate is less than 10%. Among the neuroendocrine tumors of the digestive system, only pancreatic neuroendocrine tumor has a standard treatment strategy, and there is a lack of prospective clinical research data on other gastrointestinal neuroendocrine tumors. According to the chemotherapy regimen of small cell lung cancer, etoposide plus cisplatin or irinotecan plus cisplatin is the choice of rescue therapy for advanced non-surgical or metastatic neuroendocrine tumor G3 type. However, prospective studies are needed to confirm whether there are differences in efficacy and safety between the two chemotherapy regimens. The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Etoposide 100mg/m\^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m\^2 ivggt on days 1, 2, 3, repeated every 21 days.
Irinotecan 65 mg/m\^2 ivggt on days 1, 8, Cisplatin 30 mg/m\^2 ivggt on days 1, 8, repeated every 21 days.
Objective response rate (ORR)
To compare objective response rate of the two arms from date of anti-cancer therapy until progression
Time frame: up to 2 years
Progression-free Survival (PFS)
From the first day of treatment until the date of first documented progression or date of death from any cause
Time frame: up to 2 years
Overall survival (OS)
From the first day of treatment to death or last survival confirm date
Time frame: up to 2 years
Number of Participants with Treatment-related Adverse Events
Treatment-related adverse events will be assessed by CT CAE v4.0
Time frame: up to 2 years
Assessment of Health-related quality of life
Quality of Life Questionnaire (QLQ-C30) will be evaluated since treatment begins. At the end of the trail, the differences between the two indicators will be compared with Mixed-effects model repeated measures (MMRM), where the baseline is scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline will be statistically described.
Time frame: up to 2 years
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