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

NCT06387810 | Recruiting Phase 2

• 1 other identifier: MA-PC-II-010
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

perioperative treatment, irinotecan liposome II

Outcome Measures

Primary Outcomes (1)

• event free survival

  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.

  5 years

Secondary Outcomes (4)

• overall survival

  5 years

• R0 resection rate

  2 years

• R1 excision rate

  2 years

• adverse event

  5 years

Study Arms (1)

Combined treatment group

EXPERIMENTAL

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).

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

Interventions

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

irinotecan liposome II: 60mg/m2, intravenously for at least 90min, D1, administered every 2 weeks; oxaliplatin: 85 mg/m2, intravenous infusion, D1, every 2 weeks; calcium leucovorin: 400 mg/m2, 30±10min intravenously, D1, every 2 weeks; 5-fluorouracil: 2400 mg/m2 intravenously for 46-48 hours or according to study Center clinical practice, D1, administered every 2 weeks. Irinotecan liposome II, oxaliplatin, LV and 5-FU were given successively, and corresponding prophylactic administration could be selected according to clinical needs.

Also known as: surgery

Combined treatment group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Wenming Wu, doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenming Wu, doctor

CONTACT

+86 010-69156053; doctorwuu@126.com

+86 010-69156053 Wu, doctor

CONTACT

+86 010-69156053; doctorwuu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: April 17, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-04

Locations

CN (1)