Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT07238283
Phase
PHASE3
Status
Recruiting
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Conditions

  • First-line Treatment of Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
662 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
    Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
  • Active Comparator: Treatment group B
    nab-paclitaxel in combination with gemcitabine

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From study start until target OS events have occurred (approximately 18 months after last patient enrollment) ]

Central Contacts