New treatment for advanced pancreatic cancer using HR070803 with chemotherapy
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.
This study is testing a new treatment combining HR070803 with chemotherapy to see if it helps people with advanced pancreatic cancer live longer compared to the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 778 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05751850 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of HR070803 in combination with oxaliplatin and 5-fluorouracil/leucovorin (5FU/LV) compared to the standard treatment of nab-paclitaxel and gemcitabine for patients with advanced pancreatic cancer who have not received prior treatment. The study aims to improve overall survival rates in this patient population. Participants will be monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults with untreated, histologically confirmed metastatic pancreatic cancer and an ECOG performance status of 0 or 1.
Not a fit: Patients with pancreatic cancer types other than ductal adenocarcinoma or those with CNS metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced pancreatic cancer.
How similar studies have performed: Other studies have shown promise in using combination therapies for pancreatic cancer, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ECOG performance status 0 or 1 2. Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease. 3. Life expectancy of greater than or equal to3 months. 4. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1) 5. Able and willing to provide a written informed consent Exclusion Criteria: 1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor; 2. Known history of central nervous system (CNS) metastases. 3. Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment; 4. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jun Zhang
- Email: Jun.zhang@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.