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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05810402
Eligibility Criteria:
Inclusion Criteria:
* Patients of at least 18 years old,
* Patients with advanced hepatocellular carcinoma or HCC with indication for first-line PD-1 or PD-L1 immunotherapy in MDT, without prior systemic therapy,
* The diagnosis of HCC is established according to imaging criteria (LI-RADSv2018 criteria) or after histological evidence,
* Advanced HCC defined by BCLC stages B and C,
* Patients with oral consent.
Exclusion Criteria:
* Administration of a previous systemic anti-tumor treatment (immunotherapy or chemotherapy or targeted therapy)
* No personal history of neoplasia in the previous 5 years
* No personal history of systemic inflammatory diseases
* No immunosuppressive treatment or treatment that could modify immunity (anti-TNF...)
* No affiliation or non-beneficiary of a Social Security system;
* Vulnerable persons according to article L1121-6 of the CSP ;
* Persons of full age who are protected or unable to give their consent according to article L1121-8 of the CSP;
* Pregnant or breastfeeding women according to article L1121-5 of the CSP.
* Non-inclusion due to follow-up difficulties (transfer, insufficient motivation, poor compliance, priority associated pathology in care, etc.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05810402
Study Brief:
Protocol Section:
NCT05810402