The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
CEND-1 will be provided as concentrate for solution to be administered via IV injection.
Gemcitabine will be provided as solution to be administered via IV infusion.
Nab-paclitaxel will be provided as solution to be administered via IV infusion.
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Time frame: Approximately 36 months
Overall Survival (OS)
OS is defined as the duration from randomization to the time point when death occurs due to any cause.
Time frame: Approximately 36 months
Progression Free Survival(PFS)
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Time frame: Approximately 36 months
6-month PFS rate
6-month progression-free survival (PFS) rate.
Time frame: Approximately 36 months
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
Time frame: Approximately 36 months
Disease Control Rate (DCR)
DCR was defined as the percentage of confirmed CR, PR or stable disease at the best response as assessed by investigator evaluation per RECIST 1.1.
Time frame: Approximately 36 months
Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs)
Adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events are included. The investigator should carry out judgment for investigational drug correlation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From the subject signs the ICF to 30 days after the last dose of study drug was administered.