advanced hepatocelullar carcinoma
Conditions
Interventions
B: Atilizumab Combined with Bevacizumab (T+A)
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1). The patient voluntarily joined this study and signed an informed consent form; 2). Between the ages of 20 and 70, regardless of gender; 3). Hepatocellular carcinoma diagnosed clinically or pathologically, accompanied by at least one untreated lung metastatic lesion that is measurable (according to RECIST v1.1, the length diameter of the measurable lesion on spiral CT scan is = 1.0cm); 4). Liver function Child A or B 5). Able to swallow tablets normally, ECOG score: 0-1 points 6). Expected survival time = 12 weeks 7). The following requirements are met for important organ functions (no blood components (such as albumin), cell growth factors, or other corrective treatment drugs should be used within 14 days before the first medication): Hemoglobin = 90g/L Neutrophil count = 1.5 × 109/L Platelet count = 60 × 109/L Serum albumin count = 30g/l Total bilirubin = 1.5 * ULN (7 days before the first medication) ALT and AST = 3 * ULN (7 days before the first medication) ? AKP=2.5*ULN Serum creatinine = 1.5 * ULN 8). Hepatitis B infection status: HBV-DNA2000 copies/ml, oral antiviral drugs should be taken at least one week before the start of treatment; 9). Non surgical sterilization or reproductive age female patients are required to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of treatment; Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 72 hours before enrollment in the study; And it must be non lactating.
Exclusion criteria
Exclusion criteria: 1). HCC patients who have received chemotherapy, targeted or immune therapy within the past month; 2). Patients with liver tumor burden greater than 50% and clear brain metastasis; 3). Patients with clinically symptomatic ascites who require puncture, continuous drainage, or have received ascites drainage in the past 3 months, except for those who only show a small amount of ascites on imaging but do not have clinical symptoms; 4). There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) heart failure of level 2 or above, unstable angina pectoris; (2) Have experienced myocardial infarction within 1 year; (3) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (4) Patients with severe hyperthyroidism or hypothyroidism. 5). Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or undergoing thrombolytic or anticoagulant treatment, allowing prophylactic use of low-dose aspirin, low molecular weight heparin, etc; 6). Within the first 3 months of randomization, there have been significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, esophageal and gastric varices at risk of bleeding, hemorrhagic gastric ulcers, or vasculitis. If there is a positive stool occult blood test during the baseline period, a follow-up examination is required. If it still does not turn negative, gastroscopy and colonoscopy are required. If the gastroscopy indicates severe esophageal and gastric varices with red signs, it cannot be included in the group; 7). Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); 8). Urinary routine tests indicate that urine protein is =++and it has been confirmed that the 24-hour urine protein content is>1.0g; 9). Patients who have previously received radiation therapy, TACE, hormone therapy, and have been studied for less than 4 weeks prior to treatment completion (last medication); The use of molecular targeted drugs is not affected, but should be avoided as much as possible. Patients who have not recovered to = CTCAE level 1 due to adverse events caused by previous treatment (excluding hair loss); 10). The patient has an active infection and has an unexplained fever of = 38.5 ? or a baseline white blood cell count of = 15 * 10 ^ 9/l within 7 days before medication; 11). HCV, HIV or syphilis infection; 12). Other malignant tumors within the past 3 years or at the same time as the patient; 13). Patients with long-term headaches or migraines that cannot be relieved by medication; 14). Researchers believe that individuals who are not eligible to participate in this study due to other reasons, such as comorbidities with severe mental illness, drug abuse, family or social factors, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;ORR;Liver function; | — |
Countries
China
Contacts
Public ContactShuqun Cheng
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed