Beijing Cancer Hospital
Beijing, China
Location status: Recruiting
NCT Number: NCT07079228
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine [AG]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
QLS31905 will be administered as an IV infusion.
Nab-paclitaxel will be administered as an IV infusion.
Gemcitabine will be administered as an IV infusion.
Placebo will be administered as an IV infusion.
Time frame: Up to 48 months
OS is defined as the time from randomization to deathdue to any cause.
Time frame: Up to 48 months
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: Up to 48 months
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: Up to 48 months
Time frame: Up to 48 months
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: Up to 48 months
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Contact information is provided by the study sponsor or research team.
Jihui Hao, M.D
CONTACT
Lin Shen, M.D
CONTACT
Qilu Pharmaceutical Co., Ltd.
Industry
A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
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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