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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07081633
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
* Must not have received prior systemic therapy for unresectable HCC.
* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
* Child-Pugh Score class A.
* ECOG performance status of 0 or 1 at enrollment.
* At least 1 measurable lesion per RECSIT 1.1 guidelines
Exclusion Criteria:
* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
* History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
* Clinically meaningful ascites.
* Patients with main portal vein thrombosis.
* Active or prior documented GI bleeding.
* Patient currently exhibits symptomatic or uncontrolled hypertension.
* Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
* Uncontrolled intercurrent illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07081633
Study Brief:
Protocol Section:
NCT07081633