NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nal-IRI+Oxaliplatin+5-FU/LV+PD-1, Gemcitabine + albumin-paclitaxel+PD-1.
- Who it may be relevant to
- Registry conditions: Locally Advanced Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug nal-IRI+Oxaliplatin+5-FU/LV+PD-1
These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles. - Drug Gemcitabine + albumin-paclitaxel+PD-1
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
Primary outcome measures
- mPFS [Time frame: Up to 12 months]
Secondary outcome measures (3)
- mOS [Time frame: Up to 24 months]
- ORR [Time frame: Up to 12 months]
- DCR [Time frame: Up to 12 months]
Eligibility criteria
Inclusion criteria
- 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;
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- FirstNanjingMU — Nanjing
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing
Identifiers
NCT: NCT06494514 · CSPC-DEY-PC-JS02