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

ConditionLocally Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDu Juan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NALIRINOX combined with PD-1 synchronous sequential SBRTExperimental treatment 2 interventions
Group B: AG combined with PD-1 synchronous sequential SBRTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

mPFS

Time from randomization to disease progression and/or death.

Time frame
Up to 12 months

Secondary outcomes

1

mOS

Time from randomization to death

Time frame
Up to 24 months
2

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 12 months
3

DCR

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.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Du Juan

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor institution

Source ClinicalTrials.gov
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