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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04777851
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated Patient Informed Consent Form (PICF)
* ≥ 18 years-old at the time of PICF signature
* Confirmed diagnosis of HCC
* Intermediate-stage HCC, defined as follows:
* Multinodular HCC localized to the liver
* No evidence of MVI or EHS
* Not amenable to curative treatment
* Child-Pugh Class A
* ECOG PS 0 or 1
* ALBI grade 1 or 2
* Beyond up-to-seven criteria
* Disease amenable to TACE or TARE and no contradiction to intra-arterial treatment
* Measurable disease by CT or MRI as per RECIST 1.1
* No prior systemic therapy or loco-regional therapy for HCC
* Adequate hematologic and organ function
* Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures
* Women of childbearing potential (CBP) must have confirmed negative serum pregnancy test
* Use of highly-effective contraceptive methods in women of CBP and men
* Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection are eligible if they meet criteria as defined within the protocol
Exclusion Criteria:
* No measurable tumor of a diffuse infiltrative HCC type.
* Fibrolamellar HCC, sarcomatoid HCC or mixed hepatocellular/ cholangiocarcinoma subtypes.
* Clinically meaningful ascites.
* Prior treatment with regorafenib, a PD-1, PD-L1/PD-L2, or cytotoxic T lymphocyte associated protein 4 (CTLA-4) inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
* Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization.
* Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.
* Requirement of systemic treatment with either corticosteroids or other immunosuppressive medications ≤ 14 days prior to randomization.
* Interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, or clinically significant acute lung diseases.
* Cardiovascular conditions as defined within the protocol.
* Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed ≤ 2 years before randomization.
* Persistent proteinuria of NCI-CTCAE v5.0 Grade 3.
* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04777851
Study Brief:
Protocol Section:
NCT04777851