The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
PDL1/TGFβ
Beijing Cancer Hospital
Beijing, China
Fudan University Shanghai Cancer Center
Shanghai, China
RP2D
Recommended Phase 2 Dose of SHR-1701
Time frame: Up to week 3
ORR
Objective Response Rate
Time frame: Up to approximately 6 months
Clinically significant toxicity
above grade 3 AEs
Time frame: Up to week 3
OS rate
9-month-overall survival rate
Time frame: From the start of treatment to 9 months
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 90 days for the last SHR-1701 dose
PFS
Progression-Free-Survival
Time frame: Up to approximately 6 months
DCR
Disease Control Rate
Time frame: Up to approximately 12 months
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Time frame: up to 2 years
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