liver cancer
Conditions
Interventions
Control group:TAE sequential thermal ablation
Experimental group:Recombinant human adenovirus type 5 injection combined with TAE sequential thermal ablation
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, and = 4; 5. ECOG physical condition score 0-1 points; 6. Child-Pugh score = 3 months; 8. The laboratory inspection meets the following standards: (1) White blood cell count >= 2.0 × 10^9/L, absolute value of neutrophils >= 3.0 × 10^9/L, platelet count >= 50 × 10^9/L; (2) INR = 50 ml/min; 9. Voluntarily participate in this study and sign the informed consent; 10. Female patients of childbearing age or male patients whose sexual partner is female of childbearing age should take effective contraceptive measures during the entire treatment period and 6 months after the last medication.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, men or women who are unwilling to take effective contraceptive measures; 2. Received any other experimental drugs, antibacterial drugs or participated in other interventional clinical trials within 4 weeks before enrollment; 3. Those who are known to be allergic to the study drug or its active ingredients, those with a history of allergy to similar biological agents, such as those with severe iodine contrast agent allergy; 4. Evidence of Child-Pugh C liver function or liver cell compensation, including refractory ascites, esophageal or gastric variceal bleeding and hepatic encephalopathy; 5. Patients with a history of active tuberculosis (TB), known human immunodeficiency virus (HIV) positive patients, and other serious infections that require treatment; 6. Patients with malignant hematological diseases, those with uncontrolled active infection, those who are using antiviral drugs or large doses of adrenal glucocorticoids; 7. There is a history of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days before enrollment; 8. Severe liver dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome), cachexia or multiple organ failure and renal dysfunction; 9. Those with bleeding tendency or abnormal coagulation mechanism; 10. Combined with medical contraindications that cannot accept any contrast-enhanced imaging examination (CT or MRI); 11. The investigator judges that the patient has other conditions that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS);Disease Control Rate (DCR);1-year overall survival rate;Quality of life score;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactLi Jianjun
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed