Combination treatment for 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
This study is testing a new combination of treatments before surgery to see if it helps people with borderline resectable pancreatic cancer have better outcomes and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06387810 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the safety and efficacy of irinotecan liposome II combined with oxaliplatin and 5-FU/LV as a perioperative treatment for patients with borderline resectable pancreatic cancer. The study involves administering neoadjuvant therapy before surgery, followed by surgical evaluation and potential postoperative adjuvant therapy. A total of 45 patients will be enrolled, and their progress will be monitored for tumor progression and survival outcomes. The trial aims to determine the effectiveness of this combination therapy in improving surgical outcomes and overall survival.
Who should consider this trial
Good fit: Ideal candidates are patients with borderline resectable pancreatic cancer who have not received prior anti-tumor therapies and meet specific health criteria.
Not a fit: Patients with non-pancreatic ductal origin pancreatic cancers or those with severe gastrointestinal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical resectability and survival rates for patients with borderline resectable pancreatic cancer.
How similar studies have performed: While there have been studies on similar combination therapies, this specific approach with irinotecan liposome II is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wenming Wu, doctor — Peking Union Medical College Hospital
- Study coordinator: Wenming Wu, doctor
- Email: doctorwuu@126.com
- Phone: +86 010-69156053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.