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NCT Number: NCT06669078

NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer

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

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Key information

Conditions

Locally Advanced Pancreatic Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Drug

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+Oxaliplain+5- FU

Drug

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

Primary outcomes

  1. 1 year OS rate

    Time frame: Up to 12 months]

    Proportion of patients alive from randomization to 1 year

Secondary outcomes

  1. R0/R1 rate

    Time frame: Up to 6 months

    Percentage of patients who achieved R0/RI resection

  2. The rate of mPR

    Time frame: Up to 6 months

    Proportion of patients who achieved mPR by post-operative specimen testing

  3. OS

    Time frame: Up to 24 months

    Time from randomization to death

  4. ORR

    Time frame: Up to 6 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.

  5. PFS

    Time frame: Up to 12 months

    Time from randomization to disease progression and/or death.

  6. Surgical resection rate

    Time frame: Up to 6 months

    Operable rate

  7. The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety]

    Time frame: From the first treatment to 28 days after the last treatment, about 6 months

    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).

Study contacts

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

Qiu Yudong M.D., Ph.D

CONTACT

[email protected]

+86-025-83106666

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Acronym: NALIRIFOX

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Nov 1, 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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