A Phase 3 interventional study of Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate and nab-paclitaxel; gemcitabine in First-line Treatment of Metastatic Pancreatic Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment
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.
Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
Drug: Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate
nab-paclitaxel in combination with gemcitabine
Drug: nab-paclitaxel; gemcitabine
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel in combination with gemcitabine
Overall survival (OS)
Time frame: From study start until target OS events have occurred (approximately 18 months after last patient enrollment)
Objective Response rate (ORR)
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
Disease Control Rate
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
Duration of Response
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: up to 6 months following the date the last patient was randomized
Progression free survival (PFS)
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.
Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months
Plan to share: Undecided
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Jiangsu HengRui Medicine Co., Ltd.