About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Nal-lRl+Oxaliplain+5- FU +PD 1
DrugNal-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.
Nal-lRl+Oxaliplain+5- FU
DrugNal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
Treatment groups
Trial outcomes
Primary outcomes
1 year OS rate
Proportion of patients alive from randomization to 1 year
Secondary outcomes
R0/R1 rate
Percentage of patients who achieved R0/RI resection
The rate of mPR
Proportion of patients who achieved mPR by post-operative specimen testing
OS
Time from randomization to death
ORR
According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: