HCC
Conditions
Interventions
single arm:Toripalimab and lenvatinib combined with SBRT and continuous hepatic arterial infusion
Sponsors
The Second Affiliated Hospital of Hainan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75, gender unlimited; 2) For hepatocellular carcinoma of BCLC stage C diagnosed by pathology or clinical diagnosis, pathological diagnosis is not typical for clinical diagnosis; 3) Only invasion of main portal vein (Vp4) was confirmed by two imaging methods. 4) Patients who had not received local antitumor therapy for hepatocellular carcinoma within 4 weeks prior to enrollment and who had received local antitumor therapy for hepatocellular carcinoma during neoadjuvant therapy could be enrolled; 5) no previous systemic therapy for HCC, including chemotherapy, targeted therapy and immunotherapy; 6) At least one measurable lesion (according to mRECIST criteria); 7) Laboratory tests meet the following requirements: platelets =50×109/L; Hemoglobin =9g/dL; Leukocyte =4×109/L; Neutrophil =1.5×109/L); Serum total bilirubin =1.5 times the upper limit of normal value (ULN), transaminase (ALT, AST)=5 times ULN; Creatinine =1.5 ULN; Urine routine results showed urine protein < 2 +; For patients with urine protein = 2+ on routine urine test at baseline, 24-hour urine collection and 24-hour protein quantification should be performed. 1g; International Standardized ratio (INR) or activated partial thrombin time (APTT)= 1.5 times ULN; 8) Child-Pugh grade A-B; 9) ECOG score 0 or 1; 10) The expected survival period is greater than or equal to 3 months; 11) Sign written informed consent and be willing to follow up
Exclusion criteria
Exclusion criteria: 1) A history of other malignancies, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin; 2) Patients with a known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; 3) Have any active autoimmune disease or history of autoimmune disease; 4) Hepatitis B virus (HBV)DNA >2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV)RNA >103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive; People infected with human immunodeficiency virus (HIV) (HIV 1/2 antibody positive); 5) Any life-threatening bleeding event occurred within 6 months prior to enrollment; 6) Severe infection in the active phase or with poor clinical control, or severe infection within 14 days before enrollment; 7) Patients with Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTcF interval =450ms for male and 470ms for female)(QTc interval calculated by Fridericia formula); Color ultrasound for upper cardiac insufficiency or cardiac ultrasound according to NYHA criteria :LVEF(left ventricular ejection fraction) 150mmHg, diastolic blood pressure > 100mmHg); 9) Uncontrolled pleural effusion, pericardial effusion, or ascites of medium or more; 10) Urine routine showed urine protein =2+ and confirmed 24-hour urine protein quantification > 1.0 g; 11) Active or uncontrolled severe infection, unexplained fever prior to initial administration (body temperature > 38.5 ° C); 12) Poor diabetes control (fasting blood glucose (FBG)>10mmol/L); 13) Present or past central nervous system metastasis; 14) Had an abdominal fistula, gastrointestinal perforation or abdominal abscess in the 2 months before joining the study; 15) Known hereditary or acquired bleeding and thrombotic tendencies; 16)Thrombosis/embolism events within the previous 6 months; 17) Inability to swallow, chronic diarrhea or intestinal obstruction, which significantly affect drug administration and absorption; 18) Received any vaccine treatment (including anti-infective vaccine, such as influenza vaccine, chickenpox vaccine, etc.) within 30 days prior to enrollment; 19) Any history of drug (including psychotropic) or alcohol dependence or abuse within the past two years; 20) Patients with severe allergy to iodine-containing contrast media; 21) Known to have a history of severe allergy to any monoclonal antibody, anti-angiogenic targeted drugs, chemotherapy and other drug ingredients in this study; 22) Pregnant or lactating women; 23) As determined by the investigator, the subjects had other factors that may have led to the forced termination of the study. 24) Participated in clinical trials 4 weeks before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month overall survival (OS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Surviva;Overall Response Rate;Duration of Response;Disease Control Rate;Overall Survival; | — |
Countries
CHINA
Contacts
Public ContactHaifeng Lin
The Second Affiliated Hospital of Hainan Medical College
Outcome results
None listed