Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT06714604
Eligibility Criteria:
Inclusion Criteria:
* Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1.2022
* Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)
* T1-4, Nx, M0 according to AJCC 8th edition
* ECOG 0-1 and considered fit for the planned chemotherapy at the local hospital and surgery at the two national centers for BR/LAPC
* Written informed patient consent
Exclusion Criteria:
* Co-morbidity precluding pancreatic surgery or chemotherapy
* Contraindications to any of the drugs in the proposed treatment regimens
* ECOG ≥2
* Neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6
* Granulocyte count \< 1500 per cubic millimetre (\< 1,5 x 109/L)
* Platelet count \< 100 000 per cubic millimetre (\< 100 x 109/L)
* Serum creatinine \> 1.5 UNL (upper limit normal range)
* Albumin \<2,5 g/dl (\<25 g/L)
* Total bilirubin \>3 x ULN
* ASAT (SGOT) and ALAT (SGPT) \>2.5 x institutional ULN
* female patients in child-bearing age not using adequate contraception, pregnant or lactating women
* mental or somatic disorders which could possibly interfere with informed consent, compliance or the planned treatments
* previous oncologic treatment for PC within the past 5 years
* participation in other clinical trial with an investigational product during the past 30 days
* Any reason according to the investigator why the patient cannot comply with the protocol or is not suitable to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06714604
Study Brief:
Protocol Section:
NCT06714604