Liver cancer
Conditions
Interventions
Group of liver cancer:Envafolimab combined with Lenvatinib
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily join the study and can sign the informed consent; 2. Aged >= 18 (at the time of signing the informed consent); 3. Patients with hepatocellular carcinoma diagnosed by pathology, without extrahepatic metastasis, without involvement of the left and right branches of the portal vein, and with indications of operable resection (Ib, II, IIIa); 4. Had not received systemic therapy containing PD-1/L1 and Lun Vatinib; 5. Measurable lesions (according to RECIST 1.1 standards, the length diameter of CT scan for non-lymph node lesions >= 10 mm and the short diameter of CT scan for lymph node lesions >= 15 mm); 6. ECOG PS score: 0-1; 7. The estimated survival is greater than 6 months; 8. The functions of vital organs meet the following requirements (excluding any blood components and cell growth factors used within 14 days) : (1) Blood routine: Neutrophil >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Hemoglobin >= 90 g/L; (2) Liver and kidney function: Serum creatinine (SCr) = 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) = 2+, the 24-hour urinary protein quantitation must show protein <= 1 g; 9. Normal coagulation function, no active bleeding and thrombosis disease: (1) International normalized ratio INR <= 1.5 x ULN; (2) Partial thrombin time APTT <= 1.5 x ULN; (3) Prothrombin time PT <= 1.5 x ULN; 10. Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive (such as an intrauterine device, contraceptive pill or condom) during the study treatment period and for 3 months after the study treatment period ends; Serum or urine HCG tests must be negative within 7 days prior to study enrollment; And must be non-lactation period; 11. Subject compliance is good, with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject is participating in other interventional clinical studies; 2. The subject has had or co-has other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ); 3. Be a candidate for or have undergone liver transplantation; 4. The subject is known to have a prior allergy to macromolecular protein preparations, or to drugs or any excipients applied; 5. Subjects with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery) are not included; Subjects who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Patients with asthma requiring medical intervention with bronchodilators were not included; 6. Subjects who were taking immunosuppressant, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose > 10 mg/day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment; 7. 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 arrhythmias requiring treatment or intervention; 8. The subjects were still using TCM immunomodulators within 2 weeks before enrollment; 9. Subjects had severe active infection or unexplained fever > 38.5 degree C during screening and prior to initial administration (as determined by the investigator, subjects could be enrolled with fever due to tumor); 10. Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA >= 1000 IU/ml; Hepatitis C reference: HCV RNA >= 1,000 IU/ml); Chronic hepatitis B virus carriers with HBV DNA < 2,000 IU/ml must also receive antiviral therapy during the trial to be enrolled; 11. Live vaccine was administered less than 4 weeks before or possibly during the study; 12. The subject has a known history of psychotropic substance abuse, alcoholism, or drug use; 13. The subjects received traditional Chinese medicine treatment within 4 weeks before the first treatment; 14. The investigator considers that the subjects should be excluded from the study if, in the judgment of the investigator, they have other factors that may lead to the termination of the study, such as other serious medical conditions (including mental illness) requiring concomitant 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 |
|---|---|
| rate of pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary pathological response rate;R0 excision rate;Objective Response Rate (ORR) assessed according to RECIST v1.1;1 year recurrence free survival (RFS);Incidence of adverse events (AEs) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactLiu jun
Shandong Provincial Hospital
Outcome results
None listed