Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Location contact
Wenming Wu
PRINCIPAL_INVESTIGATOR
Yupei Zhao
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07238283
This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Wenming Wu
PRINCIPAL_INVESTIGATOR
Yupei Zhao
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel in combination with gemcitabine
Time frame: From study start until target OS events have occurred (approximately 18 months after last patient enrollment)
Time frame: up to 6 months following the date the last patient was randomized
ORR is defined as the percentage of participants who have a best overall response of complete response (CR) or partial response (PR), per RECIST 1.1.
Time frame: up to 6 months following the date the last patient was randomized
The study is designed to evaluate the disease control rate with advanced pancreatic cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD).
Time frame: up to 6 months following the date the last patient was randomized
DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
Contact information is provided by the study sponsor or research team.
Jiangsu HengRui Medicine Co., Ltd.
Industry
Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
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.