NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy 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-lRl+Oxaliplain+5- FU +PD 1, Nal-lRl+Oxaliplain+5- FU.
- Who it may be relevant to
- Registry conditions: Locally Advanced Pancreatic Cancer. Basic parameters: 18 years — 75 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
- Center list to be confirmed — check the primary protocol.
- 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 Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
Overview
The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
Interventions
- Drug Nal-lRl+Oxaliplain+5- FU +PD 1
Nal-lRl+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle. - Drug Nal-lRl+Oxaliplain+5- FU
Nal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
Primary outcome measures
- 1 year OS rate [Time frame: Up to 12 months]]
Secondary outcome measures (7)
- R0/R1 rate [Time frame: Up to 6 months]
- The rate of mPR [Time frame: Up to 6 months]
- OS [Time frame: Up to 24 months]
- ORR [Time frame: Up to 6 months]
- PFS [Time frame: Up to 12 months]
- Surgical resection rate [Time frame: Up to 6 months]
- The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety] [Time frame: From the first treatment to 28 days after the last treatment, about 6 months]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically confi rmed pancreatic cancer;
- ECOG performance no more than 1;
- Radiographically assessed as locally advanced pancreatic cancer according ;
- No previous anti-tumor therapy;
- Able and willing to provide a written informed consent.
Exclusion criteria
- Prior anti-tumor therapy of any kind;
- Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
- Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
- Patients with bleeding tendency;
- 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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06669078 · CSPC-DEY-PC-JS06