Status:
UNKNOWN
Nalirinox Neo-pancreas RAS Mut ctDNA Study
Lead Sponsor:
Fundación de investigación HM
Collaborating Sponsors:
Syntax for Science, S.L
Conditions:
Resectable Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Pancreatic cancer has an unfavorable prognosis with a reduced possibility of long-term survival. The only treatment with curative potential is surgery, but it is only possible in 15-20% of cases. The...
Eligibility Criteria
Inclusion
- Male or females, aged 18 years or older
- Histologically or cytologically confirmed diagnosis of PDAC
- Candidates for pancreatic cancer surgery (no comorbidities that can exclude for surgery)
- Life expectance of at least 12 months
- Carbohydrate antigen 19-9 (CA19-9) levels \< 500 U/ml
- ECOG performance status ≤ 1
- Adequate bone marrow function:
- Hemoglobin \>9 g/dL
- Platelets \>100.000 µL
- Absolute neutrophil count (ANC) \>1500 µl
- Serum albumin \> 3 g/dL
- Adequate hepatic function:
- Aspartate aminotransferase (AST) \<3 upper limits of normal (ULN)
- Alanine Aminotransferase (ALT) \<3 ULN
- Total Bilirubin \< 1.5 ULN. If values are \> 1.5 external drainage with a stent is allowed.
- Adequate renal function:
- \- Clearance of creatinine (ClCr) \>60 ml/min
- Sexually active men and women of childbearing potential must use efficient contraceptive methods. Contraceptive methods comprise: oral contraceptives, intrauterine devices, sexual abstinence, tubal ligation, IUD, barrier methods or another contraceptive considered appropriate by the investigator. Women of childbearing potential must have a negative serum pregnancy test before study entry.
- Agree to participate and signed the ICF.
Exclusion
- Patients with metastatic disease
- Patients ≥ 75 years.
- Uncontrolled coagulopathy
- Patients with a contraindication to surgery (locally advanced disease or patients not amenable to pancreatic surgery due to a previous comorbidity)
- Patients with prior or concurrent malignant disease that required treatment with chemotherapy in the past.
- Previous cytotoxic therapy within 36 months for other no-cancer disease (ie arthritis rheumatoid)
- 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
- Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule
- Human immunodeficiency virus (HIV) positivity, active Hepatitis B or Hepatitis C infection.
- 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.
- Pregnant or breast-feeding women.
- Any medical condition that, based on investigator's criteria, places the subject at risk, makes the subject ineligible or may jeopardize protocol compliance.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04010552
Start Date
May 1 2019
End Date
November 1 2023
Last Update
August 2 2022
Active Locations (3)
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1
Hestia Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
2
Hospital Universitario Madrid Sanchinarro
PAU de Sanchinarro, Madrid, Spain, 28050
3
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 80034