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NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer
NCT06494514 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
In plain English
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Official title
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
About this study
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 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.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-01
Estimated completion: 2027-04-01
Last updated: 2024-07-10
Interventions
Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1Drug: Gemcitabine + albumin-paclitaxel+PD-1
Primary outcomes
- • mPFS (Up to 12 months)
Sponsor
Du Juan · other
Contacts & investigators
ContactJuan Du, M.D. Ph.D · contact · dujunglyy@163.com · +86-025-83106666
ContactJuan Du · contact · dujunglyy@163.com · 02583106666
InvestigatorJuan Du · principal_investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
InvestigatorMin Tu · study_director, The First Affiliated Hospital with Nanjing Medical University
All locations (2)
FirstNanjingMUNot Yet Recruiting
Nanjing, Jiangsu, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, Jiangsu, China