Clinical trial · Interventional
Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer
Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer:A Prospective, Single-arm, Multicenter, Phase II Study
NCT06387810CI-TRIAL-00078704undeterminedunknownPhase 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 is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients.
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 |
|---|---|---|---|
| Borderline Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan liposome II combined with 5-FU/LV and oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined treatment group
- description
- After screening and signing informed consent, patients who met the admission requirements received 4 cycles of neoadjuvant therapy with irinotecan liposome II combined with 5-FU/LV and oxaliplatin before surgery. Surgery was performed within 2 to 4 weeks after the end of neoadjuvant therapy. 4 to 6 weeks after surgery, 4 cycles of postoperative adjuvant therapy with irinotecan liposome II combined with 5-FU/LV and oxaliplatin was performed according to the investigator's judgment (once every 2 weeks, a 2-week cycle).
- interventionNames
- Drug: irinotecan liposome II combined with 5-FU/LV and oxaliplatin
Primary outcomes (1)
- measure
- event free survival
- timeFrame
- 5 years
- description
- The time between the date the subject started treatment and the occurrence of tumor progression leading to inoperability, postoperative recurrence/metastasis, or death, whichever occurred first.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Inclusion Criteria: * According to the NCCN Clinical Practice Guidelines for Pancreatic Cancer (2024.V1 edition), patients with critically resectable pancreatic cancer. * Have at least one measurable lesion as a target lesion (according to RECIST v1.1); * Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeting, immunotherapy, etc.) or investigational drug therapy; * ECOG: 0 \~ 1; * Expected survival ≥3 months; * Adequate organ and blood function Exclusion Criteria: * Pancreatic cancer of non-pancreatic ductal origin includes patients with pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatic blastoma, and solid pseudopapillary tumor * Severe gastrointestinal dysfunction * Severe infection occurred within 4 weeks prior to initiation of treatment (CTCAE \> Grade 2) * Blood clotting is abnormal, has a tendency to bleed, or is receiving thrombolytic or anticoagulant therapy * Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 6 months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention * Known allergy to irinotecan liposome II, other liposome products, oxaliplatin, 5-FU, calcium leucovorin, and any component of the above products * Known peripheral neuropathy (CTCAE≥ Grade 3) * In the investigator's judgment, subjects had other factors that might have led to their being forced to terminate the study, such as non-adherence to the protocol, other serious medical conditions (including mental illness) requiring combined treatment, clinically significant abnormalities in laboratory test values, or family or social factors that might affect subjects' safety or the collection of trial data
References
Publications (0)
Data not yet available
No reference posted for this study.