The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
NCT Number: NCT05493995
It is a trial to assess the efficacy and safety of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as first-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, 210008, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Penpulimab 200 mg administered intravenously every 3 weeks.
Other names: AK105
12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
125mg/m^2,administered intravenously on days 1 and 8 of every 21-day cycle.
1.0g/m^2, administered intravenously on days 1 and 8 of every 21-day cycle.
Time frame: up to 3 years
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1).
Time frame: up to 3 years
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.
Time frame: up to 3 years
Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Time frame: up to 3 years
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG.
Acronym: PAAG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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