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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04042805
Eligibility Criteria:
Inclusion Criteria:
* Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
* Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
* No previous systemic anticancer treatment or TACE treatment
* Age ≥18 years
* ECOG performance status: 0-1
* Child Pugh score≤7
* Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
* Life expectancy ≥12 weeks.
* Patients must be able to understand and willing to sign a written informed consent document
Exclusion Criteria:
* Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
* History of hepatic encephalopathy or liver transplantation
* Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
* Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity
* With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable.
* Evidence of active pulmonary tuberculosis (TB).
* Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
* History of allergic reactions to related drugs
* Pregnant women, nursing mothers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04042805
Study Brief:
Protocol Section:
NCT04042805