This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.
63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Disitamab Vedotin
Gemcitabine
Object Response Rate, ORR
Defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time frame: up to 12 months
Disease Control Rate, DCR
Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1
Time frame: up to 12 months
Progress Free Survival, PFS
Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.
Time frame: up to 12 months
Over Survival, OS
Defined as time from randomization until the date of death due to any cause.
Time frame: up to 12 months
Adverse Events (AE)
NCI-CTCAE v5.0
Time frame: up to 12 months
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