This is a multi-center, open-label, phase Ib study evaluating safety and efficacy of the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with neuroendocrine tumors who have failed in previous systemic treatment. 40 patients are enrolled and injected with the humanized anti-PD-1 antibody 3mg/mg every 2 weeks until disease progresses or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically.
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(each cycle is 21 days))
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
Duration of response (DOR)
Duration of Response by irRC and RECIST 1.1
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
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: Every 3 months after last visit up to 2 year after last patient first treatment
Immune Response Criteria by irRECIST (immune response duration of response)
Immune Response Criteria by irRECIST and as per BIRC (immune response duration of response)
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Immune Response Criteria by irRECIST (immune response overall response rate)
Immune Response Criteria by irRECIST and as per BIRC (immune response overall response rate)
Time frame: baseline, every 8 weeks up to 1 year after last patient first treatment
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Biochemical response
Changes from baseline in chromogranin-A
Time frame: baseline, 6th week, 16th week
Correlation analysis of PD-L1/CD8 expression of tumor and ORR
Changes from baseline in PD-L1/CD8 expression
Time frame: 3 years
Correlation analysis of circulating tumor cells (CTC) and ORR
Changes from baseline of circulating tumor cells (CTC)
Time frame: baseline, 8th week