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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 sites120 target enrollmentOctober 30, 2024

ConditionsLocally Advanced Pancreatic Cancer

InterventionsNal-lRl+Oxaliplain+5- FU +PD 1 Nal-lRl+Oxaliplain+5- FU

DrugsNal-lRl+Oxaliplain+5- FU +PD 1 Nal-lRl+Oxaliplain+5- FU

Overview

Phase: Phase 2
Intervention: Nal-lRl+Oxaliplain+5- FU +PD 1
Conditions: Locally Advanced Pancreatic Cancer
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment: 120
Primary Endpoint: 1 year OS rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 30, 2024

End Date

October 15, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Responsible Party

Sponsor

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.

Arms & Interventions

NALIRINOX combined with PD-1 synchronous sequential SBRT group

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.

Intervention: Nal-lRl+Oxaliplain+5- FU +PD 1

NALIRIFOX group

Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.

Intervention: Nal-lRl+Oxaliplain+5- FU

Outcomes

Primary Outcomes

1 year OS rate

Time Frame: Up to 12 months]

Proportion of patients alive from randomization to 1 year

Secondary Outcomes

R0/R1 rate(Up to 6 months)
The rate of mPR(Up to 6 months)
OS(Up to 24 months)
ORR(Up to 6 months)
PFS(Up to 12 months)
Surgical resection rate(Up to 6 months)
The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety](From the first treatment to 28 days after the last treatment, about 6 months)