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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05845502
Eligibility Criteria:
Inclusion Criteria:
1. With advanced hepatocellular carcinoma (HCC) confirmed by histopathology;
2. With stage C according to the Barcelona liver cancer grading criteria (BCLC) or with stage B who are ineligible for locoregional/locoregional therapy progression;
3. Unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy;
4. Through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (GPC3) ;
5. With at least one stable evaluable target lesion according to RECIST 1.1 criteria, which was defined as: non-nodal lesion longest diameter ≥10 mm, or nodal lesion short diameter ≥15 mm;
6. Age 18-80, male or female;
7. Karnofsky Performance Status (KPS)≥80;
8. Stable vital signs and expected survival at least 12 weeks.
9. If HBsAg or HBcAb is positive, HBV-DNA \< 200 IU/ml and to receive anti-HBV therapy ((Entecavir or tenofovirdisoproxil) for at least 14 days prior to the start of study treatment;
10. Blood Routine: WBC≥2.5×109/L, PLT≥60×109/L, Hb≥9.0g/dL, LY≥0.4×109/L;
11. Blood biochemistry: Alb≥30g/L, Lipase and Amylase ≤1.5 ULN, Serum creatinine ≤1.5 ULN, creatinine clearance ≥40mL/min, ALT≤5 ULN, AST≤5 ULN, Total Serum bilirubin ≤2.5 ULN, prothrombin time ≤6s;
12. Be able to understand and sign an informed consent form
Exclusion Criteria:
1. With uncontrolled active infections;
2. No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation.
3. With previous history of encephalopathy.
4. With active acute or chronic virus, germ infection;
5. Diagnosed with HIV infection or active hepatitis, HBV, HCV infection or other serious infectious diseases;
6. Other serious medical conditions that may limit participation in the trial (such as poorly controlled diabetes (treated Glycated hemoglobin HbA1c \> 7%) , severe heart failure (left ventricular ejection fraction (LVEF) \< 45%) , myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, pulmonary embolism, chronic obstructive pulmonary disease, Interstitial lung disease, pulmonary function test FEV1 \< 60% predicted, gastric ulcer, history of gastrointestinal bleeding, or definite gastrointestinal bleeding tendency) ;
7. Ascites more than 5cm;
8. The proportion of liver replaced by tumor≥70%, or with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver;
9. Prior solid organ transplantation or waiting for organ transplantation (including liver transplantation);
10. Prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy.
11. Long-term systemic steroid therapy or patients with autoimmune diseases;
12. With a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study;
13. Have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation.
14. Had received cell therapy previously but ineffective,after physical examination not allowed to received CAR-NK therapy by investigator's judgement;
15. Pregnant or lactating women;
16. Inappropriate to participate in this clinical trial by investigator's judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05845502
Study Brief:
Protocol Section:
NCT05845502