Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07238283

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

Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-12-09

662

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status of 0 or 1
  • Histologically or cytologically confirmed pancreatic cancer not previously treated for metastatic disease
  • Life expectancy of at least 3 months
  • Presence of at least one measurable lesion according to RECIST 1.1 criteria
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Pancreatic cancer originating from extrapancreatic ductal epithelium types such as neuroendocrine carcinoma, acinar cell carcinoma, pancreatoblastoma, or solid-pseudopapillary tumor
  • History of central nervous system metastases
  • Severe infections (greater than CTCAE grade 2) requiring inpatient treatment within 4 weeks before enrollment or intravenous antibiotics within 2 weeks before enrollment
  • Uncontrolled cardiac conditions including NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 6 months, or significant arrhythmias requiring treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

Loading map...

Research Team

Z

Zengquan Gu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here