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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT07157969
Eligibility Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
2. Age ≥18 years at the time of signing informed consent, regardless of gender.
3. Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
4. BCLC Stage B or C.
5. At least one measurable lesion per RECIST 1.1.
6. ECOG score of 0-1.
7. Child-Pugh liver function class A or B.
8. Life expectancy ≥ 3 months.
9. Adequate hematological and organ function.
Exclusion Criteria:
1. Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
2. Pregnant or breastfeeding women.
3. Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
4. Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
5. History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
6. Presence of unhealed severe wounds, active ulcers, or untreated fractures.
7. Active autoimmune disease or history of autoimmune disorders.
8. Significant history of gastrointestinal diseases.
9. Significant history of cardiovascular or cerebrovascular diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07157969
Study Brief:
Protocol Section:
NCT07157969