Liver cancer
Conditions
Interventions
Experimental group: Envafolimab and Lenvatinib
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before enrollment; 2. Age 18-75 years old; 3. Clinically diagnosed hepatocellular carcinoma (HCC); 4. Unresectable patients with stage IV or III CNLC; 5. Patients assessed by researchers as not suitable for interventional therapy or patients themselves do not accept interventional therapy; 6. Measurable lesions (according to RECIST 1.1 standards, the length of CT scan for non-lymph node lesions =10 mm, and the short diameter of CT scan for lymph node lesions =15 mm); 7. Have not received any anti-tumor systemic therapy, including but not limited to immunotherapy, targeted therapy, anti-tumor Chinese medicine therapy, etc.; 8. Child-Pugh score =7 points; 9. Adequate organ function; 1) Blood routine: white blood cell (WBC) =3.5×10^9/L, Absolute Neutrophil Count (ANC) 1.5×10^9/L, Platelet (PLT) =100×10^9/L, Hemoglobin (HGB) =90g/L; 2) Liver function: serum Total Bilirubin (TBIL) =1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) =3×ULN; 3) Renal function: serum Creatinine (Cr) =1.5×ULN, or creatinine clearance =50 mL/mi (using the standard Cockcroft-Gault formula) : 4) Coagulation function: International Normalized Ratio (INR) =1.5 /PT=1.5×ULN, aPTT=1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT and INR are within the prescribed range of anticoagulants. 10. Estimated survival =3 months; 11. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Serum HCG testing was negative within 7 days prior to study enrollment, and the patient must be non-lactating; Men should agree that contraception must be used during the study period and for 6 months after the end of the study period;
Exclusion criteria
Exclusion criteria: 1. Refuse to sign the informed consent or accept the follow-up; 2. The subject has had or concurrently suffered from other malignant tumors; 3. Patients who have previously received systematic antitumor therapy; 4. Is a current liver transplant candidate or has undergone a liver transplant; 5. There is a risk of bleeding, or coagulation dysfunction, or is receiving thrombolytic therapy; Esophageal or gastric variceal bleeding in the last 6 months; 6. Known subject is previously allergic to macromolecular protein preparations or applied pharmaceutical ingredients; 7. The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs can not maintain thyroid function in the normal range, or previous thyroid surgery, long-term replacement therapy such as thyroxine after surgery; Subjects with vitiligo or complete remission of asthma in childhood could be included as adults without any intervention; Patients with asthma requiring medical intervention with bronchodilators were excluded.) 8. Subjects who are taking immunosuppressants, or systemic, or absorbable local hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks prior to enrollment; 9. The subjects were still using Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment; 10. 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; 11. 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; 12. Live vaccine was administered less than 4 weeks before or possibly during the study period; 13. The subject has a known history of psychotropic substance abuse, alcohol abuse, or drug use; 14. 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 lead to the forced termination of the study, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Surgical conversion rate;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYefu Liu
Liaoning Cancer Hospital & Institute
Outcome results
None listed