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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT04387695
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Child-Pugh score ≤ 7
* Performance status: ECOG score ≤ 2
* HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
* the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
* No previous therapy for HCC
* at least one measurable target lesion according to RECIST 1.1
* Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
* Serum total bilirubin ≤ 2 x ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
* Creatinine ≤ 1.5 x ULN
* No plan for pregnancy or breast feeding. Active contraception.
* Willing to give informed consent
Exclusion Criteria:
* Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
* Complete obstruction of hepatic outflow
* Uncontrolled ascites of hepatic encephalopathy
* Prior liver transplantation
* Positive for human immunodeficiency virus (HIV)
* Active gastric or duodenal ulcer
* Other uncontrolled comorbidities or malignancy
* Inability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04387695
Study Brief:
Protocol Section:
NCT04387695