Primary liver cancer
Conditions
Interventions
lenvatinib + camrelizumab +TACE:lenvatinib + camrelizumab +TACE
lenvatinib + camrelizumab:lenvatinib + camrelizumab
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years; 2) Barcelona Clinic Liver Cancer (BCLC) was stage B or C and was not resectable; 3) Liver function Child-Pugh grade A or good grade B (<=7 points); 4) ECOG PS physical status score 0 or 1; 5) Histopathologically or clinically confirmed hepatocellular carcinoma (American Association for the Study of Liver Diseases Diagnostic Criterion); 6) No systemic antitumor therapy for advanced liver cancer was received before initial administration.
Exclusion criteria
Exclusion criteria: 1) Patients had previously received targeted drugs, anti-PD or anti-PD-L1 inhibitors. 2) Patients with distant metastasis. 3) Patients with recurrent liver cancer. 4) Poor patient compliance. 5) Patients with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA > 103 copies /ml; Hepatitis B surface antigen (HBsAg); Positive HCV was excluded. 6) Absolute poor blood supply or arteriovenous shunt of TACE could not be performed in tumor lesions. 7) A known history of human immunodeficiency virus (HIV) infection. 8) Known tumors of the central nervous system, including metastatic brain disease. 9) Any life-threatening bleeding event occurred within 30 days prior to enrolment, including the need for blood transfusion, surgery or local treatment, and continuous medication. 10) History of organ allotransplantation. 11) Any history of active autoimmune disease or autoimmune disease. 12) Uncontrolled pleural effusion, pericardial effusion, or moderate or greater ascites. 13) known or suspected allergy to the study drug or any drug related to this study. 14) Any instability or condition that may compromise patient safety and study compliance. 15) Pregnant or lactating patients. Fertile women must have a negative pregnancy test within 7 days before starting study medication. Both men and women enrolled in the study were required to use adequate barrier contraception during the study. 16) Is participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Operative conversion rate;Overall Survival, OS;Disease Control Rate, DCR;Duration of Response, DOR;Time to Response, TTR;Adverse Event, AE;Recurrence free survival, RFS; | — |
Countries
China
Contacts
Public ContactFeixiang Wu
Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed