The purpose of this study is to explore the efficacy and safety of chidamide combined with sintilimab in chemotherapy-refractory advanced high-grade neuroendocrine neoplasm.
This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Six patients with high-grade neuroendocrine neoplasm will be enrolled in the first stage. If more than one complete or partial responses were seen at planned interim analysis, the additional 17 patients will be recruited in the second stage and a total of 23 patients will be treated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.
200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGObjective Response Rate (ORR)
Percentage of participants with complete response and partial response, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Time frame: Up to 2 years
Disease Control Rate (DCR)
Percentage of participants with complete response, partial response, and stable disease assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time from the date of enrollment until progression or death, whichever is first met
Time frame: Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years
Overall Survival (OS)
Time from the date of enrollment until death
Time frame: Time from the date of enrollment to the earliest of documented death, assessed up to 3 years
Treatment-related Adverse Events (Safety)
Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03)
Time frame: Up to 2 years
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