Primary liver cancer
Conditions
Interventions
Treatment group:Upon enrollment, they will receive one week of stereotactic radiotherapy, 20Gy-40Gy, 3-5f, and upon completion of radiotherapy, initiate envolizumab therapy, 400mg, subcutaneously, unt
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.signed written informed consent prior to enrollment; 2. aged 18-75 years; 3. clinically confirmed diagnosis of hepatocellular carcinoma (HCC) by imaging or histology or cytology; 4. already treated with palliative ablation or incomplete after radical ablation (e.g., primary nodule > 3 cm or number of multiple tumors > 3 or lesions invading the parenchyma of blood vessels, bile ducts, etc. assessed by the investigator as incomplete ablation) Subjects. 5. ECOG score: 0-2; 6. Child-Pugh score =70×10^9/L, Hemoglobin (HGB) >=70×10^9/L, and Hemoglobin (HGB) >=70×10^9/L; Blood count: 1.5×10^9/L. Hemoglobin (HGB) >=90g/L; (2) Liver function: serum Total Bilirubin (TBIL) =28 g/L; Alkaline Phosphatase (ALP) =3 months;
Exclusion criteria
Exclusion criteria: 1. subjects with prior or concurrent other malignancies. 2. risk of bleeding, or coagulopathy, or undergoing thrombolytic therapy; 3. the subject has a known prior allergy to large protein preparations or components of applied drugs; 4. the subject has any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, the presence of an abnormal thyroid function (hyperthyroidism/hypothyroidism) and the use of medications that do not maintain the thyroid function in the normal range, or previous thyroid surgery requiring postoperative long-term thyroxine and other drug replacement therapy; subjects with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; subjects with asthma that requires medical intervention with bronchodilators may not be included) 5. subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and continue to do so within 2 weeks prior to enrollment 6. subjects who are still using herbal medicines or other immunomodulators within 2 weeks prior to enrollment; 7. has clinically symptomatic ascites or pleural effusion that cannot be controlled medically and requires therapeutic puncture or drainage 8. patients with clinical symptoms or disease of the heart that is not well controlled, such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 9. severe infections that are active or poorly controlled clinically. Severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, or unexplained fever >38.5 degrees occurring during the screening period, prior to the first dose (at the investigator's discretion, subjects may be enrolled for fever arising from a tumor); 10. patients with a history and current objective evidence of pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, and severely impaired lung function; known syphilitic infections requiring treatment; and active tuberculosis (TB), who are on anti-tuberculosis therapy or have been on anti-tuberculosis therapy within 1 year prior to the first dose. 11. Subjects with congenital or acquired immune function defects, such as HIV-infected individuals, or active hepatitis (transaminases do not meet the inclusion criteria, Hepatitis B reference: HBV DNA =2000 IU/ml or >=10^4 copies/ml; Hepatitis C reference: HCV RNA >=2000 IU/ml or >=10^4 copies/ml; below the above criteria after nucleoside analog antiviral therapy. (can be enrolled); chronic hepatitis B virus carriers with HBV DNA <10^4 IU/ml must receive concurrent antiviral therapy during the trial to be enrolled; 12. vaccination with live vaccine less than 4 weeks prior to study drug administration or possibly during the study; 13. the subject has a known history of psychotropic substance abuse, alcoholism, or drug addiction 14. in the opinion of the investigator, the subject should be excluded from the study, e.g., in the judgment of the investigator, the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;overall survival, OS; | — |
Countries
China
Contacts
Public ContactXue Jun
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed