Nalirinox Neo-pancreas RAS Mut ctDNA Study
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 05/31/2020 |
| Pirmasis pateikimas: | 07/02/2019 |
| Numatytas registravimas pateiktas: | 07/04/2019 |
| Pirmas paskelbtas: | 07/07/2019 |
| Paskutinis atnaujinimas pateiktas: | 06/04/2020 |
| Paskutinis atnaujinimas paskelbtas: | 06/08/2020 |
| Faktinė studijų pradžios data: | 04/30/2019 |
| Numatoma pirminio užbaigimo data: | 07/31/2021 |
| Numatoma studijų užbaigimo data: | 10/31/2021 |
Būklė ar liga
Intervencija / gydymas
Drug: NALIRINOX treatment
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: NALIRINOX treatment Patients will be treated with NALIRINOX, a combination of three chemotherapy agents: 5- FU/LV, nal-IRI, and oxaliplatin. Treatment regimen will consist of 8 cycles of neoadjuvant NALIRINOX prior to surgery and trial duration is expected to be 24 months. | Drug: NALIRINOX treatment NALRINOX: combination of three chemotherapy agents: 5- FU/LV, nal-IRI, and oxaliplatin |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 comorbidities 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 ≤ 1 7. Adequate bone marrow function: - Hemoglobin >9 g/dL - Platelets >100.000 µL - Absolute neutrophil count (ANC) >1500 µl - Serum albumin > 3 g/dL 8. 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. 9. Adequate renal function: - Clearance of creatinine (ClCr) >60 ml/min 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. Exclusion Criteria: 1. Patients with metastatic disease 2. Patients ≥ 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 cytotoxic 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. |
Rezultatas
Pirminės rezultatų priemonės
1. 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 KRAS positive and negative patients [8 weeks after surgical intervention]
Antrinės rezultatų priemonės
1. R0 resection [Through the study completion (estimated to be 15 months)]
2. 1-year survival and Overal survival (OS) in baseline KRAS+ and KRAS- subjects [Through the study completion (estimated to be 15 months)]
3. Progression Free Survival (PFS) [Through the study completion (estimated to be 15 months)]
4. Assessment of the proportion of KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
5. Assessment of the number of KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
6. Impact on R0 resection for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
7. Impact on histological tumour response for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
8. Impact on PFS for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
9. Impact on 1-year survival for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
10. Impact on OS for KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX [Through the study completion (estimated to be 15 months)]
11. Number of AEs and SAEs (according to CTCAE) to describe the safety profile of the neoadjuvant NALIRINOX scheme [Through the study completion (estimated to be 15 months)]
