RecruitingPhase 3NCT05751850

HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer

HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

778 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug combination (HR070803 plus oxaliplatin, 5-FU, and leucovorin) against the standard regimen (nab-paclitaxel plus gemcitabine) as a first-line treatment for advanced pancreatic cancer. Researchers hope the new combination will be more effective. **You may be eligible if...** - You are 18 or older with confirmed advanced pancreatic cancer that has not been treated yet - You have at least one measurable tumor on scans - Your general health is adequate (ECOG 0 or 1) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Your pancreatic cancer is a rare subtype (neuroendocrine, acinar cell, pancreatoblastoma, or solid pseudopapillary tumor) - Your cancer has spread to the brain - You have significant heart problems (heart failure, unstable angina, recent heart attack, or serious arrhythmia) - You have had a severe infection requiring hospitalization in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate

DRUGnab-paclitaxel; gemcitabine

nab-paclitaxel in combination with gemcitabine


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05751850