Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

20 to 80 years old men and women;
HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy;
Patients who are not a transplant candidate;
Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy;
Patients who have a life expectancy of at least 6 months;
Child-Pugh Class should be A or B;
Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3;

Patients who have clinical laboratory test results as follows:

Absolute neutrophil count ≥ 1,500/µL or White blood cell ≥ 4,000/µL
Hemoglobin ≥ 8.5 g/dL
Platelet count ≥ 50,000/µL
Blood creatinine ≤ 1.5 x upper limit of normal
Total bilirubin < 3 x upper limit of normal
Albumin ≥ 2.8 g/dL
International normalized ratio (INR) / Partial thromboplastin time (PTT) < 1.5 x upper limit of normal
Written informed consent.

Exclusion Criteria:

Patients who have infiltrative or diffuse HCC;
Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease;
Patients who plan to receive systemic chemotherapy or target therapy;
Patients with other malignant tumor within the past 5 years before treatment;
Pregnant or lactating patients;
Patients with hemorrhage/bleeding event;
Patients with uncontrolled infections;
Known or suspected allergy to the investigational agent or any agent given in association with this trial;
Patients who have current Human Immunodeficiency Virus (HIV) or Treponema Pallidum (TP) infection;
Patients who are suffering from serious autoimmune disease;
Patients who have had long term use of or are using an immunosuppressant;
History of organ transplant;
Prior use of any anti-cancer treatments within 30 days or 5 half-lives (whichever is longer), except TACE, PEIT and RFA therapy;
Patients who have participated in another clinical study and received treatment within 30 days prior to the screening visit;
Mental conditions rendering the patient incapable of understanding the nature, scope, and consequences of the study;
Other situations that the researchers considered unsuitable for this study.