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

Trial ID: NCT06387810

Interventional - Phase 2 - Unknown status

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

• Borderline Resectable Pancreatic Cancer

Interventions

• irinotecan liposome II combined with 5-FU/LV and oxaliplatin

Eligibility

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

Sponsor

Peking Union Medical College Hospital

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows