Hepatocellular carcinoma
Conditions
Interventions
Treatment group:Lenvatinib+Tislelizumab+Radiotherapy + Hepatic Artery Infusion Chemotherapy (HAIC)
Sponsors
Zhongshan Hospital Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Between 18 and 70 years old; 2. Sign informed consent and be willing to participate in this study; 3. Life expectancy is more than 12 weeks. 4. In accordance with the clinical diagnostic criteria of hepatocytes or puncture biopsy, hepatocellular carcinoma was diagnosed histologically and staged according to the following clinical diagnostic criteria of hepatocellular carcinoma: AASLD standards of the United States in 2018 and the guidelines for diagnosis and treatment of Primary liver Cancer of the Chinese Health Commission (2019 Edition), clinically diagnosed as stage BCLC C or CNLC IIIa hepatocellular carcinoma which is not suitable for hepatectomy. And complicated with portal vein tumor thrombus (Japanese tumor thrombus type VP4, or Chinese Cheng's type III, type IV). 5. At least one lesion can be measured by contrast-enhanced CT or MRI. 6. Patients with newly diagnosed HCC who had not received any local or systematic treatment for HCC in the past; 7. ECOG score 0 or 1; 8. Child-Pugh score = 90 g/L. b. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L. c. Platelet count >= 75 × 10^9/L blood biochemical examination (no albumin was used in 14 days before screening): a. Albumin >= 28 g/L. b. Total bilirubin = 2 × normal upper limit (ULN); c. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 3 × ULN; d. Creatinine <= 1.5 × ULN. Blood coagulation function: a. International standardized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; b. Activated partial thromboplastin time (APTT) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Accompanied by malignant primary tumors of other systems; 2. Patients with a history of angina pectoris, myocardial infarction and other severe cardiovascular diseases; patients with other serious diseases who could not tolerate the side effects of this study; epilepsy and other central nervous system disorders; 3. History of acute and chronic glomerulonephritis and nephropathy; history of hyperthyroidism or hypothyroidism and depression; 4. The patient was positive in pregnancy, breastfeeding or pregnancy test; 5. Autoimmune disease or immunodeficiency active disease or history, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease; 6. Cerebrovascular accident, renal insufficiency, depression and other mental disorders; 7. History of organ transplantation; 8. There are other reasons why the researchers think that they can not be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Conversion resection rate; | — |
Countries
China
Contacts
Public ContactLiu Pingguo
Zhongshan Hospital Xiamen University
Outcome results
None listed