liver cancer
Conditions
Interventions
Experimental group:Radiotherapy combined with envafolimab and lenvatinib
Control group:Envolizumab in combination with lenvatinib
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit. 2. Patients with hepatocellular carcinoma diagnosed by imaging or pathological examination. 3. Those who are inoperable after initial treatment, those who cannot be re-operated after relapse, those who are not suitable for RFA/TACE, those who recur or remain after RFA/TACE treatment and cannot be re-operated and those who cannot be re-operated and RFA/TACE. 4. Patients voluntarily give up other treatment methods except radiotherapy, immunization, and targeting. 5. Expected survival period >= 3 months. 6. Child-Pugh score: grade A or better grade B (=29g/L. 7. ECOG score: 0-2 points. 8. There are measurable lesions that meet the mRECIST criteria. 9. Hematological examinations meet: HB>=90g/L, ANC>=1.5x10^9/L, PLT>=75x10^9/L, WBC>=3.0x10^9/L. 10. Patients with hepatitis B and C virus infection should have effective antiviral therapy, HBV DNA <100IU/ml, HCV DNA < 100IU/ml. 11. Agree to join the group, be willing to cooperate with clinical research, and sign the informed consent. 12. Female patients of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1. History of esophagogastric varices bleeding, hepatic encephalopathy, massive ascites, and abdominal infection; 2. The tumor is close to the organs at risk such as the intestine, and it is difficult to tolerate radiotherapy; the residual liver volume is less than 700ml, and it is difficult to tolerate radiotherapy; 3. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation; 4. Previous use of immunosuppressive drugs within 14 days before immunotherapy, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (i.e. no more than 10 mg/day of prednisolone or other corticosteroids at an equivalent pharmacophysiological dose); 5. Known severe allergic reactions to immune or targeted drugs; 6. Administer a live attenuated vaccine within 4 weeks before the first dose or during the study period; 7. The presence of peripheral neuropathy > grade 1; 8. Have any active autoimmune disease or a history of autoimmune disease; 9. Have ever been diagnosed with any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 11. Hypertension, which cannot be well controlled by antihypertensive drug treatment (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 12. Abnormal coagulation function (APTT>1.5xULN), with bleeding tendency or receiving thrombolytic therapy, anticoagulation therapy or antiplatelet therapy, etc.; 13. Known hereditary or acquired bleeding and thrombotic tendencies, such as: hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.; 14. Patients with obvious coughing up blood within 2 months before entering the study; 15. Patients at risk of gastrointestinal bleeding, including the following: (1) Active peptic ulcer lesions; (2) Those with a history of melena and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it is necessary to review the stool routine within 1 week, and those who are still (+) or (+/-) must undergo gastroscopy, if there are ulcers, bleeding diseases, and the treating physician believes that there is a potential bleeding risk; 16. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, that occurred within 6 months before entering the study; 17. Complicated infection requiring drug intervention within 4 weeks before the first dose (such as: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5 degrees C during screening/before the first dose; 18. Participated in any other drug clinical research within 4 weeks before the first administration; 19. Known history of psychotropic substance abuse or drug use; 20. There are other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHan Yunwei
Affiliated Hospital of Southwest Medical University
Outcome results
None listed