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

NCT ID: NCT07173387

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-12-31

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.

Detailed Description

The study will assess the combination of NALIRIFOX (a chemotherapy regimen including liposomal irinotecan) and SBRT in patients with locally advanced unresectable pancreatic cancer. NALIRIFOX consists of liposomal irinotecan, oxaliplatin, 5-FU, and leucovorin, administered in 10-12 cycles every two weeks. SBRT will be applied after a variable period of chemotherapy, randomzing either early or late in the treatment course. The study's main endpoint is progression-free survival (PFS), which is the time from the start of treatment to disease progression or death. Secondary endpoints include ORR, DCR, and OS, providing a comprehensive evaluation of the treatment's effectiveness. Furthermore, the safety profile of the combination will be evaluated, focusing on adverse events using the NCI-CTCAE version 5.0. A total of 42 patients will be enrolled, with an expected follow-up duration of 24 months. The study is designed to explore whether this combined modality can improve outcomes for patients.

Conditions

Pancreatic Cancer

Study Design

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

Study Groups

Early SBRT after NALIRIFOX Treatment

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.

Group Type: EXPERIMENTAL

NALIRIFOX (liposomal irinotecan-based chemotherapy).

Intervention Type: 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.

Stereotactic Body Radiation Therapy (SBRT).

Intervention Type: 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.

Late SBRT after NALIRIFOX Treatment

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.

Group Type: EXPERIMENTAL

NALIRIFOX (liposomal irinotecan-based chemotherapy).

Intervention Type: 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.

Stereotactic Body Radiation Therapy (SBRT).

Intervention Type: 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.

Interventions

NALIRIFOX (liposomal irinotecan-based chemotherapy).

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.

Intervention Type: DRUG

Stereotactic Body Radiation Therapy (SBRT).

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

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

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinbo Yue

Director of Department Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinbo Yue, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Countries

China

Central Contacts

Jinbo Yue, Doctor

Role: CONTACT

jbyue@sdfmu.edu.cn

0531-67626442

Facility Contacts

Jinbo Yue, Doctor

Role: primary

jbyue@sdfmu.edu.cn

0531-67626442

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Other Identifiers

SDZLEC2025-364-02

Identifier Type: -

Identifier Source: org_study_id