Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-110
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

45 Participants
are divided into 1 treatment group