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Trial 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
NCT ID:
NCT06494514
Condition:
Locally Advanced Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Oxaliplatin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
nal-IRI+Oxaliplatin+5-FU/LV+PD-1
Description:
These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is
performed in third cycles.
Arm group label:
AG combined with PD-1 synchronous sequential SBRT
Arm group label:
NALIRINOX combined with PD-1 synchronous sequential SBRT
Intervention type:
Drug
Intervention name:
Gemcitabine + albumin-paclitaxel+PD-1
Description:
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is
performed in third cycles.
Arm group label:
AG combined with PD-1 synchronous sequential SBRT
Arm group label:
NALIRINOX combined with PD-1 synchronous sequential SBRT
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
FirstNanjingMU
Address:
City:
Nanjing
Zip:
025
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Min Tu
Phone:
13585181045
Phone ext:
025
Contact backup:
Last name:
Min Tu
Phone:
13585181045
Phone ext:
025
Email:
tumin1215@163.com
Facility:
Name:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
025
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Du, M.D. Ph.D
Phone:
+86-025-83106666
Email:
dujunglyy@163.com
Investigator:
Last name:
Min Tu
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Du Juan
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06494514
