Hepatocellular carcinoma
Conditions
Interventions
Envolizumab in combination with lenvatinib and TACE:TACE
Envolizumab 300mg, subcutaneous injection, d1, q3w
Renvastinib 8mg, QD (weight < 60kg), 12mg, QD (weight =60kg)
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before enrollment; 2. Age 18-70 years old; 3. Clinical diagnosis of hepatocellular carcinoma (HCC) by histology or cytology or alpha-fetoprotein or imaging; 4. Inoperable patients with stage C or B BCLC; 5. Have =1 measurable lesion (according to RECIST 1.1 criteria); 6. Have not received any anti-tumor systemic therapy, including but not limited to immunotherapy, targeted therapy, anti-tumor, etc.; 7.ECOG score: 0 ~ 1; 8.Child-Pugh score =7 points; 9. Adequate organ function: (1) Blood routine: WBC=3.0×10^9/L; ANC=1.5×10^9/L; PLT=100×10^9/L; HGB=90 g/L; (2) Liver function: AST=2.5×ULN; ALT=2.5×ULN; TBIL=1.5×ULN; (3) Renal function: Cr=1.5×ULN or CrCl =60 mL/min; (4) Coagulation function: INR=1.5, APTT=1.5×ULN; (5) No obvious abnormality in electrocardiogram; 10. Estimated survival =3 months; Fertility and lactation plan during the study treatment period and for 24 months after the study.
Exclusion criteria
Exclusion criteria: 1. The subject has had or concurrently suffered from other malignant tumors; 2. Is a current liver transplant candidate or has undergone a liver transplant; 3. There is a risk of bleeding, or coagulation dysfunction, or is receiving thrombolytic therapy; 4. Known subject is previously allergic to macromolecular protein preparations or applied drug ingredients; 5. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, thyroid dysfunction, vitiligo, asthma, etc.); 6. Subjects were taking immunosuppressants, or systemic, or absorbable local hormone therapy for immunosuppressive purposes (doses >10mg/ day of prednisone or other therapeutic hormones) and continued to use within 2 weeks prior to enrollment; 7. The subjects were still using traditional Chinese medicine or other immunomodulators (except thymofasin and its analogues) within 2 weeks before enrollment; 8. Ascites or pleural effusion with clinical symptoms, which cannot be controlled by drugs, require therapeutic puncture or drainage; 9. Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 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; 10. Severe infections that are active or poorly controlled clinically. Severe infection, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, in the 4 weeks prior to initial dosing, or unexplained fever >38.5 degrees during the screening period prior to initial dosing (as determined by the investigator, the subject's fever due to the tumor could be enrolled); 11. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function; A known syphilis infection requiring treatment; Active tuberculosis (TB) in people who are receiving anti-TB therapy or who have received anti-TB therapy within 1 year prior to initial drug administration. 12. Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA=2000 IU/ml or =104 copy number /ml; Hepatitis C reference: HCV RNA=2000 IU/ml or =104 copy number /ml; After nucleotide antiviral therapy, those who are lower than the above criteria can be included in the group); Chronic hepatitis B virus carriers, HBV DNA < 104 IU/ml, must also receive antiviral therapy during the trial to be enrolled; 13. Live vaccine was administered less than 4 weeks before or possibly during the study period; 14. The subject has a known history of psychotropic substance abuse, alcohol abuse, or drug use; 15. The investigator considers that the subjects should be excluded from the study, for example, if the investigator judges that the subjects have other factors that may cause the study to be forced to terminate, such as other serious illnesses (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects, or the collection of data and samples. Extrahepatic and/or cen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Countries
China
Contacts
Public ContactHuang Xiaolun186
Sichuan Cancer Hospital
Outcome results
None listed