A Phase II Study of Liposomal Irinotecan (Nal-IRI) With 5 Fluorouracil, Leucovorin, and Oxaliplatin (NALIRIFOX) in Patients With Locally Advanced Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Age ≥ 18 years old, ≤ 70 years old, male or female;

• Understand the objectives and benefits and risks of the clinical trial, voluntarily participate in and sign the informed consent form;

• ECOG score 0-1;

• The subject had histopathologically or cytologically confirmed type of pancreatic ductal adenocarcinoma

• Local progression according to the 2022 CSCO guidelines;

• Initial subjects with locally advanced pancreatic cancer who have not undergone resection of pancreatic tumor (except open exploration or internal drainage surgery), chemotherapy, targeted, or immunotherapy.

• At least one measurable pancreatic lesion per RECIST 1.1 criteria;

• Expected survival time ≥ 3 months.

• Heart, lung, liver, kidney and other major organ functions are basically normal.

⁃ Hematology tests should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days prior to hematology):

∙ White blood cell count ≥ 3.0 × 109/L and neutrophil count ≥ 1.5 × 109/L.

‣ Platelet count ≥ 100 × 109/L.

‣ Hemoglobin ≥ 90 g/L.

‣ If component blood transfusions (red blood cells, platelets, etc.) are received at screening, reexamination of hematology must be performed at 1-week intervals before further screening can be considered.

⁃ Blood chemistry tests should meet the following criteria:

∙ Plasma total bilirubin ≤ 1.5 × upper limit of normal.

‣ ALT, AST, or ALP ≤ 2.5 × upper limit of normal;

‣ Creatinine clearance ≥30 mL/min calculated by the Cockcroft-Gault formula (Cockcroft-Gault formula: male Ccr = \[(140-age) × body weight (kg)\]/\[0.818 × Scr (μmol/L)\] or Ccr = (140-age) × body weight (kg)/72 × Scr (mg/dl), and female Ccr calculated as male × 0.85);

⁃ The subject had no symptoms of cardiac insufficiency (NYHA functional class ≤ II) at baseline and had no obvious abnormalities or abnormalities in electrocardiograms that were not clinically significant.

⁃ Good compliance, voluntary compliance with this clinical trial protocol and follow-up by the investigator during the study.

⁃ Subjects of childbearing potential voluntarily take highly effective contraceptive measures in the trial.

⁃ Females must be non-lactating.

Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Rong K Jiang, MD
jiangkuirong@njmu.edu.cn
+8615312995688
Backup
Min Tu, MD
Time Frame
Start Date: 2023-12-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: NALIRIFOX
NALIRIFOX(Oxaliplatin 60 mg/m2 IV over 2 hours ; Liposomal Irinotecan 50 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion) on days 1 of a 14-day cycle.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov