Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Transarterial Chemoembolization (TACE) combined with Anti-CTLA-4 Antibody SHR-8068, Atebolizumab Monoclonal Antibody, and Bevacizumab.
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Both men and women aged from 18 to 75 years old when signing the informed consent form; 2. Patients with pathologically diagnosed HCC who could not be treated radically; 3. At least one measurable lesion according to RECIST v1.1 criteria (a locally treated lesion can be considered as a measurable lesion only if there is definite progression); 4. Barcelona Clinical staging (BCLC) stage B or C; The CNCL stage was ?B-?. 5. ECOG PS score: 0-1; 6. Child-Pugh grading score of liver function: =3 months; 8. Vital organ function should meet the following criteria: 1) Blood routine examination: no blood transfusion and no correction treatment with G-CSF or other cytokines within 2 weeks before screening; a) hemoglobin (Hb) >=90 g/L; b) absolute neutrophil count (ANC) >=1.5×10^9/L; c) platelet count (PLT) >=55×10^9/L; 2) Other tests: (no human albumin injection within 14 days before screening) a) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =28 g/L; d) serum creatinine (Cr) 1.5×ULN, creatinine clearance (CrCL) >=50 mL/min (calculated according to Cockcroft-Gault formula); e) thyroid stimulating hormone (TSH) =2+, 24-hour urinary protein quantification was required, and 24-hour urinary protein quantification =50%; 9. Female patients of childbearing potential must undergo a negative serum pregnancy test within 3 days before the first treatment; And must be non-lactating. Female patients or male patients whose partner was a female had to agree to comply with the high-potency contraceptive requirement from the time they provided informed consent until 6 months after the last dose of the study drug was administered. 10. Suitable for TACE treatment; 11. The subjects voluntarily participated in this clinical study, and signed the informed consent form, with good compliance and good cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma/hepatocellular carcinoma (with an intrahepatic cholangiocarcinoma component exceeding 30%). 2. Patients with any active, known, or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, interstitial pneumonia, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.); enrollment is allowed for Type 1 diabetes mellitus patients receiving a stable dose of insulin therapy, hypothyroidism patients who only require hormone replacement therapy, and patients with skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and have not had acute exacerbations within 1 year prior to the screening period. 3. Patients who have used corticosteroids (more than 10mg/day of prednisone or other equivalent steroids) or other immunosuppressive agents for systemic treatment within 1 month before the first treatment; in the absence of active autoimmune diseases, the inhalation or local use of corticosteroids is allowed, as well as adrenal hormone replacement therapy with a dose =140mmHg or diastolic blood pressure >=90mmHg); have a history of hypertensive crisis or hypertensive encephalopathy. 10. Have poorly controlled clinical symptoms or diseases of the heart, such as: (1) heart failure at or above Class II according to the New York Heart Association (NYHA) criteria; (2) unstable angina; (3) myocardial infarction within 1 year prior to the first treatment; (4) supraventricular or ventricular arrhythmias of clinical significance requiring treatment or intervention. 11. Known hereditary or acquired bleeding disorders (such as coagulation disorders) or thrombotic tendencies (e.g., patients with hemophilia); currently receiving anticoagulation or thrombolytic therapy [preventive use of low-dose aspirin (<=100mg/day) and low molecular weight heparin (<=40mg/day) is permitted]. 12. Within 3 months before the first treatment, significant bleeding events or a clear bleeding tendency occurred (e.g., gastrointestinal bleeding, high-risk esophageal varices, or bleeding ulcers). A positive fecal occult blood test at baseline requires a gastroscopy; severe findings such as major gastric ulcers or esophageal varices disqualify patients from enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Time To Response (mTTR);Disease Control Rate (DCR);Duration of Response (DoR);Progression-Free Survival (PFS);Time To Failure (TTF);Overall Survival (OS);Changes in the immune microenvironment before and after Transarterial Chemoembolization (TACE); | — |
Countries
China
Contacts
Public ContactJiansong Ji
Lishui Central Hospital
Outcome results
None listed