Combining irinotecan liposome with oxaliplatin and tegafur for pancreatic cancer treatment
Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer
This study tests if a new combination of chemotherapy drugs can help people who have had surgery for pancreatic cancer recover better and stay cancer-free longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06361316 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of irinotecan liposome injection when combined with oxaliplatin and tegafur as adjuvant chemotherapy for patients who have undergone surgery for pancreatic cancer. The focus is on patients with histologically confirmed resected ductal pancreatic adenocarcinoma. The treatment aims to improve outcomes following macroscopic complete resection of the tumor. Participants will be monitored for both efficacy and safety throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are patients with resected ductal pancreatic adenocarcinoma who have a good performance status and can provide informed consent.
Not a fit: Patients with severe gastrointestinal issues or those unable to eat orally may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with pancreatic cancer after surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using combination therapies for pancreatic cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ECOG performance status 0 or 1. 2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). 3. ECOG performance status 0 or 1. 4. Life expectancy of greater than or equal to 6 months. 5. Able and willing to provide a written informed consent. Exclusion Criteria: 1. Patients who cannot eat orally and have gastric emptying disorder after surgery; 2. Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living; 3. Patients who cannot eat orally and have gastric emptying disorder after surgery; 4. Patients who cannot eat orally and have gastric emptying disorder after surgery;
Where this trial is running
Nanjing, Jiangsu
- FirstNanjingMU — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: KuiRong Jiang, archiater — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: KuiRong Jiang, archiater
- Email: Jiangkuirong@163.com
- Phone: 15312995688
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.