This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC.
This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC. PD-1 antibody SHR-1210 is a humanized monoclonal antibody, and the heavy chain is immunoglobulin G4 (IgG4), the light chain is immunoglobulin κ (IgK). SHR-1210 specifically binds to PD-1 and blocks the interaction of PD-1 with its ligand (PD-L1), allowing T cells to recover against tumor immune responses. The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study. Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. Gemcitabine Other Name: Gemcitabine Hydrochloride for Injection Paclitaxel-albumin Other Name: Paclitaxel-albumin Injection
RenJiH
Shanghai, Shanghai Municipality, China
ORR:Objective Response Rate by IRC
objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1
Time frame: through study completion, an average of 2 year
ORR:Objective Response Rate by investigator
objective response rate evaluated by investigator using radiographic examination according to RECIST1.1
Time frame: through study completion, an average of 2 year
DCR: disease control rate
partial rate of subjects evaluated as CR/PR/SD in all subjects
Time frame: through study completion, an average of 2 year
DoR:duration of response
time firstly evaluated as CR or PR to time firstly evaluated as PD
Time frame: through study completion, an average of 2 year
PFS: progression-free survival
time from randomization to progression
Time frame: through study completion, an average of 2 year
OS: overall survival
time from randomization to death
Time frame: through study completion, an average of 2 year
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