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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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) 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.
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
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.
Time frame: Up to 24 months
Objective Response Rate
Defined as the percentage of patients who achieve a partial or complete response, measured by tumor shrinkage using RECIST 1.1 criteria.
Time frame: up to 24 months.
Disease Control Rate
Defined as the percentage of patients who achieve a complete response, partial response, or stable disease.
Time frame: up to 24 months.
Overall Survival
Defined as the time from the start of treatment to death from any cause.
Time frame: up to 24 months.
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