Comparing two treatments for locally advanced pancreatic cancer
A Single-center, Randomized, Interventional Controlled Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy for First-line Treatment of Locally Advanced Pancreatic Cancer
This study is testing two different treatment combinations for people with locally advanced pancreatic cancer to see which one works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06494514 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of NALIRINOX combined with PD-1 sequential radiotherapy versus AG combined with PD-1 sequential radiotherapy as first-line treatment for patients with locally advanced pancreatic cancer. Participants will receive either treatment regimen to determine which is more effective in managing their condition. The study aims to provide insights into the best therapeutic approach for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically or cytologically confirmed locally advanced pancreatic cancer who have not received prior anti-tumor therapy.
Not a fit: Patients with prior anti-tumor therapy, severe infections, autoimmune diseases, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with locally advanced pancreatic cancer.
How similar studies have performed: While there have been studies on treatments for pancreatic cancer, this specific combination approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed pancreatic cancer; 2. ECOG performance no more than 2; 3. Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines; 4. No previous anti-tumor therapy； 5. Able and willing to provide a written informed consent; Exclusion Criteria: * 1\. Prior anti-tumor therapy of any kind; 2. Severe infection (\>NCI CTC grade 2); 3.Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs; 4.Patients with bleeding tendency; 5. Pregnant or lactating women.
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- FirstNanjingMU — Nanjing, Jiangsu, China (Not_yet_recruiting)
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Juan Du — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study coordinator: Juan Du, M.D. Ph.D
- Email: dujunglyy@163.com
- Phone: +86-025-83106666
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.