A Phase 2 interventional study of Nal-lRl+Oxaliplain+5- FU +PD 1 and Nal-lRl+Oxaliplain+5- FU in Locally Advanced Pancreatic Cancer, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 2, Interventional, and Treatment
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
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nal-IRI+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 +PD 1
Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
Drug: Nal-lRl+Oxaliplain+5- FU
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.
Nal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
1 year OS rate
Proportion of patients alive from randomization to 1 year
Time frame: Up to 12 months]
R0/R1 rate
Percentage of patients who achieved R0/RI resection
Time frame: Up to 6 months
The rate of mPR
Proportion of patients who achieved mPR by post-operative specimen testing
Time frame: Up to 6 months
OS
Time from randomization to death
Time frame: Up to 24 months
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.
Time frame: Up to 6 months
PFS
Time from randomization to disease progression and/or death.
Time frame: Up to 12 months
Surgical resection rate
Operable rate
Time frame: Up to 6 months
The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety]
Using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, we analyzed the data of all subjects who received at least one study treatment. We collected and summarized the overall incidence of adverse events (AE), the incidence of grade 3 or higher AE, and the incidence of serious adverse events (SAE).
Time frame: From the first treatment to 28 days after the last treatment, about 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School