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

NCT06669078 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-DEY-PC-JS06
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

NALIRIFOX; Conversion Therapy; Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 1 year OS rate

  Proportion of patients alive from randomization to 1 year

  Up to 12 months]

Secondary Outcomes (7)

• R0/R1 rate

  Up to 6 months

• The rate of mPR

  Up to 6 months

• OS

  Up to 24 months

• ORR

  Up to 6 months

• PFS

  Up to 12 months

Study Arms (2)

NALIRINOX combined with PD-1 synchronous sequential SBRT group

EXPERIMENTAL

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.

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

NALIRIFOX group

EXPERIMENTAL

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

Drug: Nal-lRl+Oxaliplain+5- FU

Interventions

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

NALIRINOX combined with PD-1 synchronous sequential SBRT group

Nal-lRl+Oxaliplain+5- FU DRUG

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

NALIRIFOX group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confi rmed pancreatic cancer;
• ECOG performance no more than 1;
• Radiographically assessed as locally advanced pancreatic cancer according ;
• No previous anti-tumor therapy;
• Able and willing to provide a written informed consent.

You may not qualify if:

• Prior anti-tumor therapy of any kind;
• Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
• Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
• Patients with bleeding tendency;
• Pregnant or lactating women.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Central Study Contacts

Qiu Yudong M.D., Ph.D

CONTACT

+86-025-83106666; yudongqiu510@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: November 1, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share