Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This is an open-label study with no masking applied to participants, investigators, or care providers.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
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.
Intervention: NALIRIFOX (liposomal irinotecan-based chemotherapy). (Drug)
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.
Intervention: Stereotactic Body Radiation Therapy (SBRT). (Radiation)
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.
Intervention: NALIRIFOX (liposomal irinotecan-based chemotherapy). (Drug)
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.
Intervention: Stereotactic Body Radiation Therapy (SBRT). (Radiation)
Outcomes
Primary Outcomes
Progression-Free Survival
Time Frame: Up to 24 months
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.
Secondary Outcomes
- Objective Response Rate(up to 24 months.)
- Disease Control Rate(up to 24 months.)
- Overall Survival(up to 24 months.)
Investigators
Jinbo Yue
Director of Department Radiation Oncology
Shandong Cancer Hospital and Institute