Advanced primary hepatocellular carcinoma
Conditions
Interventions
Treatment group:Recombinant Human Adenovirus Type 5 Injection+Tislelizumab Injection +HAIC
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old and = 10 mm; 6. Expected survival time >= 3 months; 7. During the screening period, the laboratory inspection meets the following standards: i. White blood cell count >= 3.0*10^9/L, absolute value of neutrophils >= 3.0*10^9/L, platelets Count >= 50×10^9/L, hemoglobin>100g/L ii. INR <= 1.5, and APTT <= 1.5 times the upper limit of normal value or partial prothrombin time (PTT) <= 1.5 times the upper limit of normal value; iii. Total bilirubin <= 2.5 times the upper limit of normal value; ALT and AST <= 5 times the upper limit of normal values; Blood muscle Anhydride <= 1.5 times the upper limit of normal value. 8. Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, men or women who are unwilling to take effective contraceptive measures; 2. Diffuse liver cancer or tumors are not suitable for mRECIST standard evaluation; 3. Patients who have previously received oncolytic virus drugs (such as T-VEC); 4. Those who are known to be allergic to the study drug or its active ingredients, and those with a history of allergy to similar biological agents; 5. Confirmed active tuberculosis (TB), known human immunodeficiency virus (HIV) positive patients, and other serious infections that require treatment; 6. Having a history of immune deficiency or autoimmune diseases, or receiving long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days before enrollment; 7. Medical history of other malignant tumors (including unknown primary tumors), except for the following: cured non melanoma skin malignant tumors, cervical carcinoma in situ, stage I radical uterine cancer, radical breast ductal carcinoma in situ or lobular carcinoma in situ (currently without any systemic treatment), localized prostate cancer that is currently considered cured after radical surgery, and other solid tumors that have been cured for more than 5 years without signs of recurrence; 8. Known central nervous system tumors, including metastatic brain tumor; 9. Accompanying any unstable systemic diseases, including but not limited to: severe infection, hypertensive patients whose blood pressure cannot drop to normal after antihypertensive treatment, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction (myocardial infarction history of 6 months or more is allowed), congestive heart failure, serious arrhythmia requiring drug treatment, kidney or metabolic diseases; 10. There are medical contraindications that cannot accept any contrast-enhanced imaging examination (CT or MRI) in the merger; 11. Participants who have participated in other interventional clinical trials within 30 days prior to screening (note: subjects who have entered the follow-up period of the clinical trial can participate in this trial, provided that they have been given the last medication of the previous trial for 4 weeks); 12. The researcher determined that the patient has other circumstances that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Therapy;Duration of Response;Disease Control Rate;Progressive Free Survival;1-year overall survival rate;Changes in CD8+;Changes in Treg; | — |
Countries
CHINA
Contacts
Public Contactzhangqi
Zhongda Hospital Southeast University
Outcome results
None listed