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

NCT ID: NCT06669078

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2027-10-15

Brief Summary

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

Conditions

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NALIRINOX combined with PD-1 synchronous sequential SBRT group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

NALIRIFOX group

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

Group Type: EXPERIMENTAL

Nal-lRl+Oxaliplain+5- FU

Intervention Type: DRUG

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

Interventions

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

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.

Intervention Type: DRUG

Nal-lRl+Oxaliplain+5- FU

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qiu Yudong M.D., Ph.D

Role: CONTACT

yudongqiu510@163.com

+86-025-83106666

Other Identifiers

CSPC-DEY-PC-JS06

Identifier Type: -

Identifier Source: org_study_id