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

Du Juan

Status: Enrolling

Conditions: Locally Advanced Pancreatic Cancer

Treatments: Drug: Gemcitabine + albumin-paclitaxel+PD-1; Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1

Study type: Interventional

Funder types: Other

Identifiers

NCT06494514

CSPC-DEY-PC-JS02

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

NALIRINOX combined with PD-1 synchronous sequential SBRT

Experimental group

Description:

Nal-IRI+Oxaliplatin+5-FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.

Treatment:

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

Drug: Gemcitabine + albumin-paclitaxel+PD-1

AG combined with PD-1 synchronous sequential SBRT

Experimental group

Description:

Gemcitabine + albumin-paclitaxel +PD-1, these drugs are given on d1, d8, 21 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.

Treatment:

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

Drug: Gemcitabine + albumin-paclitaxel+PD-1