RecruitingNot ApplicableNCT06494514

NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer

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


Sponsor

Du Juan

Enrollment

40 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria1

  • \. 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.

Interventions

DRUGnal-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.

DRUGGemcitabine + 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.


Locations(2)

FirstNanjingMU

Nanjing, Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

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NCT06494514


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