unresectable locally advanced or metastatic hepatitis B-associated hepatocellular carcinoma
Conditions
Interventions
Single arm:Tirelizumab+Lenvatinib
Sponsors
Fujian Cancer Hospital, Fujian Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria may be included in this study: 1) Voluntary signed written informed consent before screening; 2) 18 years old, age: 75 years old, acceptable for both men and women; 3) ECOG score of 0-1; 4) After a clinical or pathological diagnosis of hepatocellular carcinoma, the diagnosis of hepatocellular carcinoma should meet any of the following criteria: ? hepatocellular carcinoma confirmed by histology or cytology, except fibrous lamelina, sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma; ? clinically confirmed HCC according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition); 5) With hepatitis B virus infection, hepatitis B virus (HBV) DNAA <2000 IU/ml or 10 after receiving antiviral treatment4copy /ml; 6) has not received any previous systemic therapy for HCC (mainly including systemic chemotherapy, anti-vascular therapy, molecular targeted therapy, targeting T cell co-stimulation or any other antibody or drugs of the immune checkpoint pathway, including but not limited to anti-PD-1, anti-PD-L 1 / L 2, anti-CD 137 or anti- CTLA-4 antibody), the disease progression 6 months after the end of postoperative adjuvant chemotherapy; 7) The Barcelona clinical stage of liver cancer (BCLC stage) is stage C or stage B, which is not suitable for surgery and/or local treatment; 8) Child-Pugh rating of liver function: Grade A and A good grade B (7 points), and no history of hepatic encephalopathy; 9) According to the efficacy evaluation criteria of solid tumors (RECIST 1. 1), there is at least one measurable lesion, and it can also be selected as target lesion for clear disease progression in lesions that have previously received local treatment; 10) Expected survival period exceeds 3 months 11) Normal major organ function (without corrective treatment with any blood components, cell growth factors, and albumin infusion within 14 days before obtaining laboratory examination), the following criteria are met: a. Blood routine: neutrophils 1.5 l 09/ L, platelets 75109/ L, hemoglobin of 90g / L; b. Liver function: glutamate aminotransferase (ALT) and glutamate transaminase (AST), AST and AST 5 ULN; serum albumin 28g /L; total bilirubin (TBIL) 2 ULN; alkaline phosphatase (ALP) 5ULN; c. Renal function: serum creatinine (Cr) 1.5 ULN or creatinine clearance (Ccr) 50 mL/min; d. Routine urine protein <2 +; if urine protein 2 + at baseline, 24hours urine protein quantification must be 1.0g; e. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) 1.5 ULN; f. Cardiac echocardiography: left ventricular ejection fraction (LVEF) 50%;
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria should be excluded from this study: 1) Liver surgery and/or local treatment for HCC within 4 weeks before the first study medication, except for palliative radiotherapy of bone metastatic lesions for pain relief; 2) Subjects who did not recover from any toxicity of local therapy (including interventional therapy, radiofrequency therapy, etc.), previous chemotherapy, surgery, radiotherapy, and/or complications, i.e., not reduced to grade 1 (NCI CTCAE version 5) (except for alopecia and fatigue); 3) Previous anti-tumor drug therapy (including but not limited to traditional Chinese medicine preparations with anti-tumor indications); 4) Combined with moderate or severe ascites or ascites requiring drainage, or pleural fluid or pericardial effusion requiring drainage and/or with symptoms of shortness of breath; 5) Associated with known active central nervous system metastasis (CNS) and/or cancerous meningitis; 6) With other malignant tumors (except for cured cervical carcinoma in situ, skin cancer without melanoma, or other tumors/cancers treated with radical treatment and without signs of disease for at least 5 years); 7) Combined with bleeding tendency, high bleeding risk, or coagulation dysfunction, including motor and venous thromboembolic events within 6 months before screening, including myocardial infarction, unstable angina Vascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other History of severe thromboembolism; 8) Portal vein cancer embolism involves the trunk, or both the trunk and superior mesenteric vein, or inferior vena cava cancer embolism or heart involvement; 9) Unhealed wounds, active gastrointestinal ulcers or bleeding, and fractures (excluding old fractures that have healed); 10), had ruptured esophageal or gastric varices bleeding within 6 months prior to treatment, or had known endoscopic presence of severe varices. 11), a history of gastrointestinal perforation and/or fistula, abdominal abscess, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 12), patients who had undergone major surgery within 4 weeks before enrollment or who had an expected major surgery during the study (except for diagnostic biopsy); 13) with known or suspected autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerullitis, etc.), a history of infection with human immunodeficiency virus (positive for HIV test), or with other acquired, congenital immune deficiency diseases. 14) Patients with a history of active tuberculosis or active infection or uncontrolled infection requiring systematic treatment (except for simple urinary tract infection or upper respiratory tract infection), and syphilis infection requiring treatment; 15) Subjects with a combined history of interstitial lung disease, infectious pneumonia or high suspicion of interstitial lung disease; subjects with previous drug-derived or radioactive non-infectious pneumonia were enrolled; 116) Concomitant severe internal medical conditions, such as grade III or above cardiac dysfunction (New York Heart Association [NYHA]), ischemic heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactZengqing Guo
Fujian Cancer Hospital, Fujian Medical University Cancer Hospital
Outcome results
None listed