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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT05773859
Eligibility Criteria:
Inclusion criteria
* Women over 18 years old with histologically confirmed primary epithelial ovarian cancer.
* Not amenable by primary debulking surgery and in need of neoadjuvant chemotherapy and interval debulking
* High-grade or low grade serous histology
* FIGO stage IIIb, IIIc, IVa or IVb if only lymph nodes ≤ 1cm above the diaphragm or in the groins
* Extensive abdominal spread of tumor
* WHO/ECOG performance status 0-1
* Neutrophils \>1.5x 109/L, platelets \>100x 109/L, hemoglobin \>5,6 mmol/L (9.0 g/dl), estimated glomerular filtration rate \> 45 ml/min/1.73m2 , AST/ALT \<3 x ULN, serum bilirubin \<1.5 x ULN (exception: Gilbert's syndrome is permitted)
* Expected adequacy of follow-up
* Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:
* Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments;
* or surgical sterilisation (bilateral oophorectomy or hysterectomy).
* Informed consent
Exclusion criteria
* Recurrent ovarian cancer
* Histologies other than high grade serous ovarian cancer such as, but not restricted to, endometrioid, mucinous, clear cell or carcinosarcoma
* Unable and/or unwilling to undergo standard chemotherapy and interval debulking surgery
* FIGO stage I-IIb, IIIa or IVb with liver, spleen or lung metastases or lymph nodes above the diaphragm or in the groins \> 1 cm
* History of any second malignancy, with the exception of adequately treated basal cell carcinoma, cervical cancer \> 5 years ago or early stage breast cancer \>10 years ago.
* Any serious clinical condition that may interfere with the safe administration of DC vaccinations
* Heart failure (NYHA class III/IV)
* Any uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
* Unable to undergo a tumor biopsy
* Pregnancy or insufficient anti-conception if reproduction is still possible
* Active infection of Hepatitis B, C, HIV and syphilis
* Serious other active infections
* Known allergy to shell fish
* Auto immune disease (exception: vitiligo is permitted)
* History of organ allografts
* Chronic treatment with systemic immunosuppressive drugs (i.e. more than 10 mg prednisolone equivalent)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05773859
Study Brief:
Protocol Section:
NCT05773859