Resectable Pancreatic Ductal Adenocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ONIVYDE 5 mg/ml concentrado para solución para perfusión
Product Name: irinotecan liposome injection
Pharmaceutical Form: Concentrate for solution for infus
Sponsors
Fundación de investigación de HM Hospitales
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or females, aged 18 years or older 2. Histologically or cytologically confirmed diagnosis of PDAC 3. Candidates for pancreatic cancer surgery (no cormobidities that can exclude for surgery) 4. Life expectance of at least 12 months 5. Carbohydrate antigen 19-9 (CA19-9) levels =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Patients with metastatic disease 2. Patients > or =75 years. 3. Uncontrolled coagulopathy 4. Patients with a contraindication to surgery (locally advanced disease or patients not amenable to pancreatic surgery due to a previous comorbidity) 5. Patients with prior or concurrent malignant disease that required treatment with chemotherapy in the past. 6. Previous citotoxic therapy within 36 months for other no-cancer disease (ie arthritis rheumatoid) 7. Known or suspected reactions to any component of the study medication (5-FU/LV, nal- IRI or oxaliplatin) or to components of similar chemical or biologic composition 8. Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule 9. Human immunodeficiency virus (HIV) positivity, active Hepatitis B or Hepatitis C infection. 10. Uncontrolled illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, myocardial infarction, or left ventricular ejection fraction (LVEF) < 50, among others, or psychiatric illness/social situations that would limit compliance with study requirements. 11. Pregnant or breast-feeding women. 12. Any medical condition that, based on investigator’s criteria, places the subject at risk, makes the subject ineligible or may jeopardize protocol compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the association of KRAS mutational load and histological tumor response after chemotherapy treatment in patients with PDAC. The histopathological outcome in surgical specimens will be correlated with KRAS mutational load detected in cfDNA of blood by BEAMing; Secondary Objective: - To evaluate the association of overall survival and KRAS mutational load after surgery in plasma from patients with PDAC. -To evaluate the association of progression-free survival and KRAS mutational load after surgery in plasma from patients with PDAC. -To evaluate the association of R0 resection rate and KRAS mutational load before surgery in plasma from patients with PDAC. - To evaluate the safety profile of NALIRINOX by recording the incidence of AEs. Acute and late toxicity of NALIRINOX treatment will be evaluated according to the Common Toxicity Criteria (CTC) for adverse events (AE). - To evaluate the efficacy of NALIRINOX in terms of overall survival and one-year survival. ;Primary end point(s): Proportion of subjects with a good histological tumour response in the resected specimens after neoadjuvant chemotherapy with NALIRINOX and surgical removal according to the Ryan’s classification in a dichotomic way (0-1: good; 2-3: bad) in KRAS positive and negative patients assessed by liquid biopsy and BEAMing.;Timepoint(s) of evaluation of this end point: 8 weeks after surgical intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - R0 resection, PFS, 1-year survival and OS in baseline KRAS+ and KRAS- subjects. - Assessment of the number and proportion of KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX and its impact on R0 resection, histological tumour response, PFS and 1-year survival and OS. - Description of the safety profile of the neoadjuvant NALIRINOX scheme: AEs, SAEs according to the CTCAE. ;Timepoint(s) of evaluation of this end point: Through the study | — |
Countries
Spain
Contacts
Public ContactSecretaría
Fundación de investigación de HM Hospitales
Outcome results
None listed