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:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT01984658
Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from locally advanced pancreatic cancer and have started treatment with Folfirinox but must stop because of side effects or who declined the Folfirinox treatment.
* Minimum age of 18 years old and be capable of understanding the information and giving informed consent,
* Minimum height of 155 cm,
* Expected survival time (life expectancy) of over 6 months,
* Adequate performance status £ 2 (see below\*),
Exclusion Criteria:
* Evident signs of distant metastasis at baseline
* Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis),
* Patient´s which have visit an area where there is an outbreak of West Nile virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative,
* Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation,
* Clinically significant autoimmune disorders or conditions of immune suppression,
* Haemoglobin count ≤ 7.5 mmol/l (men \& women),
* Lymphocytes below 0.3 x 109/l,
* Clinically abnormal Erythrocyte Volume Fraction (EVF),
* Body weight below 40 kg (men) and 50 kg (women),
* Pregnant or breast feeding women. Fertile women can only be included with a negative pregnancy test at screening and must use contraceptives during the study,
* Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection,
* Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
* Any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of the study endpoints difficult,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01984658
Study Brief:
Protocol Section:
NCT01984658