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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04162158
Eligibility Criteria:
Inclusion Criteria:
* According to the 2010 edition of the diagnostic criteria for primary liver cancer BCLC, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (BCLC C phase);
* Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points;
* Laboratory criteria:
1. Liver function: Child A/B, ALT \< 200 U/L, AST \< 200 U/L, Tbil \<51μmol/L
2. Renal function: Creatinine clearance ≥ 60ml/minute
3. Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB\>80 g/L
4. Cardiac function: No abnormality in cardiac enzyme and ECG
* Survival expectation is greater than 6 months;
* Patients with active hepatitis B or C were treated with the appropriate NA or DAA medication, and all patients enrolled in the group were treated with targeted drugs.
* The patient has a donor who meets the donor enrollment criteria and all patients and donors sign the Informed Consent Form;
Exclusion Criteria:
* Women who are pregnant or breast-feeding.
* Co-infected with hepatitis A, hepatitis E, AIDS or other infectious diseases.
* Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days.
* Patients with other serious systemic and psychiatric diseases.
* Exposure to any cell therapy such as, but not limited to CIK, DC, CTL , PD-1 and stem cells therapy 6 months prior to study drug administration.
* Other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04162158
Study Brief:
Protocol Section:
NCT04162158