The purpose of this study was to evaluate the preliminary safety, efficacy and PK characteristics of cend-1 in patients with advanced metastatic pancreatic ductal adenocarcinoma (Chinese population).
This study is a multi-center, non-randomized, open-label phase Ib/II clinical study carried out in Chinese patients with advanced metastatic pancreatic ductal adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The dose is specified according to the protocol. CEND-1+paclitaxel (albumin-bound type)+gemcitabine
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Safety of CEND-1 mesured by AEs, SAEs and treatment related adverse events.
Adverse events (AEs), serious adverse events (SAEs), treatment related adverse events are included. The investigator should carry out judgment for investigational drug correlation.
Time frame: 12 month
Preliminary efficacy of CEND-1 mesured by ORR, DOR, DCR, OS, PFS ect.
Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), progress-free survival (PFS), PFS rate, OS rate etc. are included.
Time frame: 12 month
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