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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed pancreatic cancer;
• ECOG performance no more than 2;
• Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
• No previous anti-tumor therapy；
• Able and willing to provide a written informed consent;
Locations
Other Locations
China
FirstNanjingMU
NOT_YET_RECRUITING
Nanjing
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Contact Information
Primary
Juan Du, M.D. Ph.D
dujunglyy@163.com
+86-025-83106666
Backup
Juan Du
dujunglyy@163.com
02583106666
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 40
Treatments
Experimental: NALIRINOX combined with PD-1 synchronous sequential SBRT
Nal-IRI+Oxaliplatin+5-FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.
Experimental: AG combined with PD-1 synchronous sequential SBRT
Gemcitabine + albumin-paclitaxel +PD-1, these drugs are given on d1, d8, 21 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.
Related Therapeutic Areas
Sponsors
Leads: Du Juan