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

A Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced Pancreatic Cancer
• Intervention / Treatment: Drug: Nal-lRl+Oxaliplain+5- FU +PD 1; Drug: Nal-lRl+Oxaliplain+5- FU

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiu Yudong M.D., Ph.D; Phone Number: +86-025-83106666; Email: yudongqiu510@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: NALIRIFOX group; Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.	Drug: Nal-lRl+Oxaliplain+5- FU; Nal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year OS rate	Proportion of patients alive from randomization to 1 year	Up to 12 months]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0/R1 rate	Percentage of patients who achieved R0/RI resection	Up to 6 months
The rate of mPR	Proportion of patients who achieved mPR by post-operative specimen testing	Up to 6 months
OS	Time from randomization to death	Up to 24 months
ORR	According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement.	Up to 6 months
PFS	Time from randomization to disease progression and/or death.	Up to 12 months
Surgical resection rate	Operable rate	Up to 6 months
The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety]	Using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, we analyzed the data of all subjects who received at least one study treatment. We collected and summarized the overall incidence of adverse events (AE), the incidence of grade 3 or higher AE, and the incidence of serious adverse events (SAE).	From the first treatment to 28 days after the last treatment, about 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Locally Advanced Pancreatic Cancer; Conversion Therapy; NALIRIFOX
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Fluorouracil
• Other Study ID Numbers: CSPC-DEY-PC-JS06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No