Clinical trial · Interventional
Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial
NCT06259058CI-TRIAL-00075064not yet recruitingPhase 1 / Phase 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 multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan liposome injection | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX
- description
- Patients receive 3 cycles of NALIRIFOX followed by SBRT (30Gy/5Fx). Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
- interventionNames
- Drug: Irinotecan liposome injection
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- Radiation: SBRT
- type
- ACTIVE_COMPARATOR
- label
- NALIRIFOX + Surgery + NALIRIFOX
- description
- Patients receive 6 cycles of NALIRIFOX. Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
- interventionNames
- Drug: Irinotecan liposome injection
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: ≥18 years old. * Histologically or cytologically proven pancreatic ductal adenocarcinoma. * Multidisciplinary assessment as borderline resectable disease. * At least one measurable lesion (according to RECIST v1.1). * No prior antitumor therapy for pancreatic cancer. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1. * The expected survival time ≥3 months. * Adequate bone marrow function as evidenced by: 1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L, 2) Platelet count ≥100×10\^9/L, 3) Hemoglobin (Hb) ≥90 g/L, 4) White blood cell (WBC) ≥3.0×10\^9/L. * Adequate hepatic function as evidenced by: 1) Serum total bilirubin ≤1.5 × upper limit of normal (ULN), 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN * Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min. * Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening. Exclusion Criteria: * Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc. * Patients with distant metastases and/or cannot complete resection. * Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment. * Active HIV, HBV, HCV infection. * Combined with uncontrollable systemic diseases. * Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction \[CTCAE v5.0\], or \> grade 1 diarrhea \[CTCAE v5.0\]). * History of allergy or hypersensitivity to drug or any of their excipients. * Patients who have chemotherapy and surgery contraindications. * Documented serum albumin ≤3 g/dL * Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration. * Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception. * Participated in other trial within 30 days before the first administration. * Patients who are not suitable to participate in this trial for any reason judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.