This is a prospective, single-armed, open label study on the efficacy and safety of sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished without disease progression or progression occurs during the treatment, the patient will enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint is progression free survival in the two steps respectively and secondary endpoint is disease control rate, overall survival and safety
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Phase 1 irinotecan 180mg/m\^2,ivgtt,90min,D1 Cisplatin 50 mg/m\^2,ivgtt,120min,D1(with hydration) Phase 2 Octreotide 0.1mg,ih,q8h,D1-14 Octreotide lar 20mg,deep i.m,D8,
Beijing Tumor Hospital
Beijing, Beijing Municipality, China
Progression Free Survival for Irinotecan plus cisplatin and octreotide
The primary objective is to investigate the overall progression free suvival for irinotecan plus cisplatin and octretide. The respective PFS of the two treatment steps will also be investigated. The result will be compared with the history treatment outcomes for patients of poorly differentiated neuroendocrine carcinoma.
Time frame: 2 years
Disease control rate
The second objective includes the disease control rate of irinotecan plus cisplatin and octretide theray.
Time frame: 2 years
Overall survival
The secondary objective includes the investigation of the overall survival for the patients receiving the sequential treatment of irinotecan plus cisplatin and octretide.
Time frame: 3 years
Safety
The secondary objective also includes the investigation on the safety profiles of the two interventions, irinotecan plus cisplatin treatment and octretide. The safety profile will be described using incidence of AEs and SAEs, using CTCAE criteria
Time frame: 3 years
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