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

Nanjing University

Status and phase: Not yet enrolling; Phase 2

Conditions: Locally Advanced Pancreatic Cancer

Treatments: Drug: Nal-lRl+Oxaliplain+5- FU; Drug: Nal-lRl+Oxaliplain+5- FU +PD 1

Study type: Interventional

Funder types: Other

Identifiers

NCT06669078

CSPC-DEY-PC-JS06

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confi rmed pancreatic cancer;
2. ECOG performance no more than 1;
3. Radiographically assessed as locally advanced pancreatic cancer according ;
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. Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
3. Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive 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)

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120 participants in 2 patient groups

NALIRINOX combined with PD-1 synchronous sequential SBRT group

Experimental group

Description:

Nal-IRI+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.

Treatment:

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

NALIRIFOX group

Experimental group

Description:

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

Treatment:

Drug: Nal-lRl+Oxaliplain+5- FU