A Phase II Trial to Assess the Evolution of KRAS Mutation Load by Liquid Biopsy in Patients with Resectable Pancreatic Ductal Adenocarcinoma Treated with Neoadjuvant NALIRINOX - Nalirinox neo-pancreas RAS mut ctDNA study

Fundación de investigación de HM Hospitales0 个研究点目标入组 20 人开始时间: 2019年1月18日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•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 < 500 U/ml
•6. ECOG performance status < or 1
•7. Adequate bone marrow function
•8. Adequate hepatic function
•9. Adequate renal function
•10. 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.
•11. Agree to participate and signed the ICF.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•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
•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.

发起方

Fundación de investigación de HM Hospitales