hepatocellular carcinoma
Conditions
Interventions
experiment group:Lenvatinib combined with Camrelizumab
Sponsors
Guangdong General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants must have any of the following criteria for an unresectable diagnosis of HCC: Histologically or cytologically confirmed HCC. HCC was clinically confirmed according to the American Association for the Study of Liver Diseases (AASLD) standards, including criteria for cirrhosis of the Liver of any cause, chronic hepatitis B or C infection. 2) According to the modified solid tumor Response Assessment criteria (mRECIST), there is at least one measurable target lesion that meets the following criteria: The liver lesions a) At least one lesion >= 1.0cm was accurately measured. b) The lesion is suitable for repeated measurement. c) The lesions showed enhancement signs in the arterial phase of CT or MRI. Liver focal a) The diameter of lymph node lesions on the short axis is >= 1.5cm in at least one dimension, unless hilar lymph nodes on the short axis are >= 2.0cm in diameter. b) The short axis diameter of non-lymph node lesions is >= 1.0cm. Imaging evidence of disease progression must be present in patients previously treated with radiation therapy or local area therapy to be considered as target lesions. 3) Patients with stage B (not applicable to transcatheter arterial chemoembolization [TACE]) or Stage C were identified according to the BCLC staging system. 4) Concurrent HBV infection: HBV surface antigen (HbsAg) positive. 5) Adequate bone marrow function is defined as: Absolute count of neutrophils (ANC) >= 1.5 * 10^9/ L; Hemoglobin (Hb) >= 8.5g/ dL; Platelet count >= 75 * 10^9/ L. 6) Adequate liver function is defined as: Albumin >= 2.8g/ dL; Bilirubin 30ml/min calculated according to the Cockcroft and Gault formulas. 9) Adequate pancreatic function, defined as amylase and lipase = 12 weeks. 14) At the time of informed consent, the patient is a male or female of at least 18 years of age (or any age determined by national law to be older than 18 years). 15) Previously, I had not received any systemic therapy for HCC (mainly including systemic chemotherapy, anti-vascular therapy, molecular targeted therapy and immunotherapy containing CTLA-4 and PD-1/PD-L1 monoclonal antibody). 16) Women of childbearing age must undergo a negative blood pregnancy test within 7 days of enrollment and agree to use a reliable and effective method of contraception during the test and within 60 days after the last dose of the test drug.For male patients whose partners are women of childbearing age, consent must be given to a reliable and effective method of contraception during the trial and within 60 days of the last dose of the experimental drug. 17) The patient participated voluntarily, gave full informed consent, signed written informed consent, and had good compliance.^
Exclusion criteria
Exclusion criteria: 1) It is known to be cholangiocarcinoma (ICC) or mixed liver cancer, sarcomatoid liver cancer, and fibre-laminoma of the liver. 2) 5 years of malignancy other than HCC; However, the localized tumors that have been studied for cure are excluded, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate. 3) Had received liver surgery and/or local therapy or experimental drug therapy for HCC within 4 weeks prior to enrollment;Palliative radiotherapy was performed on the bone metastases within 2 weeks before admission.Toxicity induced by previous treatment (except hair loss) did not return to = 3 (NCI-CTC AE V5.0) GI or non-GI fistula. 7) Tumor thrombus of main portal vein (Vp4) or inferior vena cava should be excluded. But there is a portal vein main cancer plug, but the side of the portal vein branch patency, can be allowed to join the group. 8) Previous history of serious cardiovascular and cerebrovascular diseases: Patients with NYHA class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction or cerebrovascular stroke, or poorly controlled arrhythmias were randomly diagnosed within the previous 12 months. Echocardiography LVEF (left ventricular ejection fraction) 480ms (calculated by Fridericia method, if QTc is abnormal, it can be detected 3 times in 2 minutes consecutively, and its mean value is taken); High blood pressure (BP) >= 150 mmHg and/or diastolic >= 100mmHg for which the drug is difficult to control (the average of >= 3 BP readings based on >= 2 measurements); Hypertensive crisis or hypertensive encephalopathy has occurred in the past. 9) Evidence of significant bleeding disorder or other significant bleeding tendency: Clinically significant hemoptysis or tumor hemorrhage of any cause occurred within 2 weeks prior to enrollment; Thrombosis or embolism events occurred 6 months before enrollment; Anticoagulant therapy for therapeutic purposes (except for low molecular weight heparin) was used within 2 weeks prior to enrollment. Antiplatelet therapy is required; Current or recent (10 days prior to enrollment) use of aspirin (> 325 mg/d), clopidogrel (b> 75 mg/d), or dipyridamole, ticlopidine, or cilostazol; Metastatic lesions invade the great vessels, respiratory tract, or mediastinum and are at significant risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;degradation of clinical stage;efficiency;security; | — |
Countries
China
Contacts
Public ContactHaosheng Jin
Guangdong General Hospital
Outcome results
None listed