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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: NALIRINOX combined with PD-1 synchronous sequential SBRT groupExperimental treatment 1 intervention
Group B: NALIRIFOX groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1 year OS rate

Proportion of patients alive from randomization to 1 year

Time frame
Up to 12 months]

Secondary outcomes

1

R0/R1 rate

Percentage of patients who achieved R0/RI resection

Time frame
Up to 6 months
2

The rate of mPR

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

Time frame
Up to 6 months
3

OS

Time from randomization to death

Time frame
Up to 24 months
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: