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NCT Number: NCT06494514

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

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.

Recruiting

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Key information

Conditions

Locally Advanced Pancreatic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FirstNanjingMU, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 1. 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.

Treatment and study plan

nal-IRI+Oxaliplatin+5-FU/LV+PD-1

Drug

These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.

Gemcitabine + albumin-paclitaxel+PD-1

Drug

These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.

Primary outcomes

  1. mPFS

    Time frame: Up to 12 months

    Time from randomization to disease progression and/or death.

Secondary outcomes

  1. mOS

    Time frame: Up to 24 months

    Time from randomization to death

  2. ORR

    Time frame: Up to 12 months

    According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement.

  3. DCR

    Time frame: Up to 12 months

    According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) and stable lesion (SD) after treatment and maintained the minimum time-frame requirements.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Du

CONTACT

[email protected]

02583106666 ext. +86

Juan Du, M.D. Ph.D

CONTACT

[email protected]

+86-025-83106666

Sponsors and collaborators

Lead sponsor

Du Juan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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