Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial

NCT07173387 | Not Yet Recruiting Phase 2

• 1 other identifier: SDZLEC2025-364-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter clinical study evaluates the efficacy and safety of NALIRIFOX in combination with Stereotactic Body Radiation Therapy (SBRT) for patients with locally advanced unresectable pancreatic cancer. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety assessment. The study involves two cohorts: Cohort 1 (early SBRT after 1 cycle of NALIRIFOX) and Cohort 2 (late SBRT after 6-8 cycles of NALIRIFOX). A total of 42 participants are expected to be enrolled, with a follow-up period of at least 24 months. This trial aims to provide a novel therapeutic option for this patient population.

Conditions

Pancreatic Cancer

Keywords

NALIRIFOX; liposomal irinotecan; SBRT

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  The primary outcome measure is progression-free survival (PFS), which is defined as the time from the start of treatment to the first occurrence of disease progression or death.

  Up to 24 months

Secondary Outcomes (3)

• Objective Response Rate

  up to 24 months.

• Disease Control Rate

  up to 24 months.

• Overall Survival

  up to 24 months.

Study Arms (2)

Early SBRT after NALIRIFOX Treatment

EXPERIMENTAL

Participants in this arm will receive 1 cycle of NALIRIFOX followed by early SBRT. NALIRIFOX will be continued for up to 10-12 cycles after the completion of SBRT.

Drug: NALIRIFOX (liposomal irinotecan-based chemotherapy).; Radiation: Stereotactic Body Radiation Therapy (SBRT).

Late SBRT after NALIRIFOX Treatment

EXPERIMENTAL

Participants in this arm will receive 6-8 cycles of NALIRIFOX followed by late SBRT. NALIRIFOX will be continued for up to 10-12 cycles after the completion of SBRT.

Drug: NALIRIFOX (liposomal irinotecan-based chemotherapy).; Radiation: Stereotactic Body Radiation Therapy (SBRT).

Interventions

NALIRIFOX (liposomal irinotecan-based chemotherapy). DRUG

NALIRIFOX is a chemotherapy regimen that includes liposomal irinotecan, oxaliplatin, 5-fluorouracil (5-FU), and leucovorin, administered intravenously in 10-12 cycles every two weeks.

Early SBRT after NALIRIFOX Treatment; Late SBRT after NALIRIFOX Treatment

Stereotactic Body Radiation Therapy (SBRT). RADIATION

Stereotactic Body Radiation Therapy (SBRT) is a form of high-precision radiation therapy that delivers focused radiation beams to the tumor while minimizing damage to surrounding healthy tissue. In this study, SBRT will be applied in two different timing schedules after NALIRIFOX chemotherapy: early after 1 cycle (Cohort 1) or late after 6-8 cycles (Cohort 2). The total radiation dose will be 25-50 Gy, delivered in 5 fractions.

Early SBRT after NALIRIFOX Treatment; Late SBRT after NALIRIFOX Treatment

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-75 years, both male and female. Histologically or cytologically confirmed locally advanced unresectable pancreatic cancer.
• No prior chemotherapy or radiatiotherapy for pancreatic cancer. ECOG performance status of 0-1.
• Adequate organ function as defined by the following criteria:
• Absolute neutrophil count (ANC) ≥ 1,500/μL Platelet count ≥ 100,000/μL Hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Serum creatinine ≤ 1.5 times the ULN AST/ALT ≤ 2.5 times the ULN Ability to provide written informed consent.

You may not qualify if:

• Prior history of other malignancies (except for curatively treated non-melanoma skin cancer or other cancers with a 5-year disease-free survival).
• Active infections or severe medical conditions that would interfere with the study.
• Pregnancy or breastfeeding. Known hypersensitivity to any of the study drugs. History of severe allergic reactions to liposomal formulations. Uncontrolled comorbid conditions (e.g., heart failure, chronic kidney disease, or uncontrolled diabetes).
• Participation in other clinical trials involving investigational treatments within 30 days of enrollment.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

Location

Related Publications (16)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jinbo Yue, Doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbo Yue, Doctor

CONTACT

0531-67626442; jbyue@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study with no masking applied to participants, investigators, or care providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department Radiation Oncology

Model Details: Cohort 1: Patients receive 1 cycle of NALIRIFOX followed by early SBRT, with subsequent NALIRIFOX cycles (up to 10-12 cycles) continuing after the completion of SBRT. Cohort 2: Patients receive 6-8 cycles of NALIRIFOX followed by late SBRT, with further NALIRIFOX cycles continuing post-SBRT.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)