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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06494514

Enrollment

Registered

2024-07-10

Start date

2024-04-01

Completion date

2027-04-01

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Pancreatic Cancer

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or cytologically confirmed pancreatic cancer; 2. ECOG performance no more than 2; 3. Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines; 4. No previous anti-tumor therapy； 5. 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.

Design outcomes

Primary

Measure	Time frame	Description
mPFS	Up to 12 months	Time from randomization to disease progression and/or death.

Secondary

Measure	Time frame	Description
mOS	Up to 24 months	Time from randomization to death
ORR	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.
DCR	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.

Countries

China

Contacts

Primary ContactJuan Du, M.D. Ph.D

dujunglyy@163.com+86-025-83106666

Backup ContactJuan Du

dujunglyy@163.com02583106666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026