Clinical trial · Interventional
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of 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
NCT06494514CI-TRIAL-00078686recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine + albumin-paclitaxel+PD-1 | Drug | — | UNRESOLVED |
| nal-IRI+Oxaliplatin+5-FU/LV+PD-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NALIRINOX combined with PD-1 synchronous sequential SBRT
- description
- 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.
- interventionNames
- Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1
- Drug: Gemcitabine + albumin-paclitaxel+PD-1
- type
- EXPERIMENTAL
- label
- AG combined with PD-1 synchronous sequential SBRT
- description
- 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.
- interventionNames
- Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1
- Drug: Gemcitabine + albumin-paclitaxel+PD-1
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.