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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT07077356
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged ≥18 years;
* Patients with histologically, cytologically, or clinically diagnosed hepatocellular carcinoma (HCC);
* Patients who, based on the investigator's assessment, meet the indications for liver transplantation and have expressed willingness to undergo transplantation, with a need for bridge therapy or downstaging therapy during the transplant waiting period as evaluated by the investigator;
* Positive for hepatitis B surface antigen (HBsAg) in peripheral blood;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2; (Additional inclusion criteria may be supplemented.)
Exclusion Criteria:
* History of other malignancies, except for adequately treated and non-recurrent within 5 years prior to screening basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or gastrointestinal mucosal carcinoma, which the investigator deems eligible for inclusion;
* History of or current hepatic encephalopathy; known central nervous system (CNS) metastases that are untreated or not effectively controlled by prior therapy;
* Clinically significant ascites requiring therapeutic intervention at present;
* Known clinically significant uncontrolled cardiac symptoms or diseases;
* Any active autoimmune disease or history of autoimmune diseases, including but not limited to: neurologic diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type 1 diabetes mellitus controlled with stable-dose insulin); (Additional exclusion criteria may be supplemented.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07077356
Study Brief:
Protocol Section:
NCT07077356