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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT06821958
Eligibility Criteria:
Inclusion Criteria:
* Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
* Written informed consent prior to any study procedure
* 18 years or older
* Histologically confirmed HCC
* HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies
* No prior systemic therapy for HCC
* Compensated liver function, as defined by a Child-Pugh score ≤ B7
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria
* Body weight of \> 30 kg
* Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
* If present HBV and HCV managed according to the local institutional practice
Exclusion criteria:
* Arterioembolic event including a stroke or myocardial infarction within 3 months prior to randomization Severe / unstable angina, or symptomatic congestive heart failure as defined by NYHA III/IV
* Cardiac pacemakers / ICD
* Large metal implants in the treatment area
* Current evidence of coagulopathy or bleeding diathesis
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Decompensated liver function as defined by Child Pugh ≥ B8
* Patients on a liver transplantation list
* Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
* Uncontrolled autoimmune or inflammatory disorders
* Patient not able for supine positioning (e.g. due to pain)
* Significantly altered mental status
* Pregnancy and breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06821958
Study Brief:
Protocol Section:
NCT06821958