Clinical trial · Interventional
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial
NCT07173387CI-TRIAL-00112031RAD-NALIRIFOXactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NALIRIFOX (liposomal irinotecan-based chemotherapy). | Drug | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT). | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early SBRT after NALIRIFOX Treatment
- description
- 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.
- interventionNames
- Drug: NALIRIFOX (liposomal irinotecan-based chemotherapy).
- Radiation: Stereotactic Body Radiation Therapy (SBRT).
- type
- EXPERIMENTAL
- label
- Late SBRT after NALIRIFOX Treatment
- description
- 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.
- interventionNames
- Drug: NALIRIFOX (liposomal irinotecan-based chemotherapy).
- Radiation: Stereotactic Body Radiation Therapy (SBRT).
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (16)
- BACKGROUNDWainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11. PMID 37708904
- BACKGROUNDWang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29. PMID 26615328
- BACKGROUNDShamsi M, Mohammadi A, Manshadi MKD, Sanati-Nezhad A. Mathematical and computational modeling of nano-engineered drug delivery systems. J Control Release. 2019 Aug 10;307:150-165. doi: 10.1016/j.jconrel.2019.06.014. Epub 2019 Jun 20. PMID 31229474
- BACKGROUNDFrampton JE. Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma. Drugs. 2020 Jul;80(10):1007-1018. doi: 10.1007/s40265-020-01336-6. PMID 32557396
- BACKGROUNDJanssen QP, van Dam JL, Bonsing BA, Bos H, Bosscha KP, Coene PPLO, van Eijck CHJ, de Hingh IHJT, Karsten TM, van der Kolk MB, Patijn GA, Liem MSL, van Santvoort HC, Loosveld OJL, de Vos-Geelen J, Zonderhuis BM, Homs MYV, van Tienhoven G, Besselink MG, Wilmink JW, Groot Koerkamp B; Dutch Pancreatic Cancer Group. Total neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine for resectable and borderline resectable pancreatic cancer (PREOPANC-2 trial): study protocol for a nationwide multicenter randomized controlled trial. BMC Cancer. 2021 Mar 23;21(1):300. doi: 10.1186/s12885-021-08031-z.