Actively Recruiting
A Single-center, Randomized 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
Led by Du Juan · Updated on 2024-07-10
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two treatment combinations as first-line therapy for patients with locally advanced pancreatic cancer. The study compares NALIRINOX combined with PD-1 synchronous sequential stereotactic body radiotherapy (SBRT) to gemcitabine plus albumin-paclitaxel combined with PD-1 synchronous sequential SBRT. The purpose is to determine which treatment approach may better control the cancer and improve patient outcomes. Participants receive one of two drug combinations: Nal-IRI, Oxaliplatin, 5-FU/LV plus PD-1 or gemcitabine plus albumin-paclitaxel plus PD-1. These drugs are administered in cycles—either every 28 days (days 1 and 15) for 6 to 8 cycles or every 21 days (days 1 and 8) for 6 to 8 cycles depending on the group. SBRT is given during the third treatment cycle in both groups. During the study, participants will be closely monitored through assessments including progression-free survival up to 12 months and overall survival up to 24 months. The research team will also evaluate objective response rate and disease control rate within 12 months. Participants undergo regular check-ups and imaging to measure treatment response and safety. The total study duration and follow-up allow researchers to gather detailed information on how the treatments perform and their impact on participant health.
CONDITIONS
Brief Title
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic cancer
- ECOG performance status no more than 2
- Locally advanced pancreatic cancer confirmed by imaging according to NCCN guidelines
- No previous anti-tumor therapy
- Able and willing to provide written informed consent
You will not qualify if you...
- Prior anti-tumor therapy of any kind
- Severe infection greater than NCI CTC grade 2
- Autoimmune disease or immune deficiency treated with immunosuppressive drugs
- Presence of bleeding tendency
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 cycles (approximately 4 to 8 months depending on regimen)
Participants receive either the NALIRIFOX combined with PD-1 sequential radiotherapy or Gemcitabine with albumin-paclitaxel combined with PD-1 sequential radiotherapy as first-line treatment for locally advanced pancreatic cancer. Treatment cycles occur every 28 days or 21 days depending on the drug regimen, with stereotactic body radiotherapy (SBRT) performed during the third cycle.
Visits on days 1, 8, and 21 or days 1 and 15 depending on treatment cycle schedule; SBRT during the third cycle
Trial Site Locations
Total: 2 locations
1
FirstNanjingMU
Nanjing, Jiangsu, China, 025
Not Yet Recruiting
2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 025
Actively Recruiting
Research Team
J
Juan Du, M.D. Ph.D
J
Juan Du
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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