advanced liver cancer
Conditions
Interventions
experimental group: SBRT combined with PD-1
Sponsors
Xiangyang Central Hospital in Hubei Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Strictly comply with the "guidelines for primary liver cancer diagnosis and treatment" (2019 edition) clinical diagnosis standard or confirmed by histopathology or cytology can't surgery and hepatic artery embolism chemotherapy with conventional intubation (the trunk of the portal vein tumor emboli) in patients with advanced liver cancer, and can't accept palliative surgery, metastases resection, and at least two measurable lesions and liver or lung metastases (according to the request of RECIST the measurable lesions with spiral CT scan length to diameter 10 mm or higher);[Patients with more than two enhanced imaging studies (at least stage 3 (CT/MRI/CEUS) indicated liver malignancy; or patients with previous surgical resection and pathologically confirmed liver malignancy]; 3. Child-pugh liver function rating: Grade A or better Grade B (= 12 weeks; 7. The patient had hepatitis B and had HBV DNA = 29 g/L; E) ALT and AST<5ULN; F) TBIL ULN 1.5 or less; G) 1.5 ULN BUN or less; 9. Women of childbearing age must have a pregnancy test (serum or urine) that is negative within 7 days of enrollment and are willing to use an appropriate method of contraception during the test and 8 weeks after the last dose of the test drug.For men, surgical sterilization or consent to the use of an appropriate method of contraception during the trial period and 8 weeks after the last dose of the experimental drug; 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Received any local treatment (including but not limited to surgery, radiation therapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 3 months prior to participating in the study; 2. The patient has any active autoimmune disease or a history of autoimmune disease; 3. The patient is receiving immunosuppressive or systemic hormone therapy for immunosuppression (>10 mg/ day prednisolone or other therapeutic hormones); 4. Severe allergic reactions to other monoclonal antibodies; 5. A history of hematemesis within three months or clinically assessed as having bleeding risk or a clear tendency of gastrointestinal bleeding, such as: esophageal varicose veins with bleeding risk, locally active ulcer lesions, fecal occult blood >= (++) not eligible for admission;If fecal occult blood (+) is required, gastroscopy is required; 6. Ascites and pleural fluid with clinical symptoms require therapeutic puncture or drainage; 7. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure b> 90 mmHg). 8. Suffering from myocardial ischemia and myocardial infarction II class above, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); 9. According to the NYHA standard III ~ IV level cardiac insufficiency or heart colour to exceed examination: LVEF, left ventricular ejection fraction 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 13. Patients with central nervous system metastases or known brain metastases; 14. Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 15. Urine routine showed urinary protein >= ++ or confirmed 24-hour quantitative urinary protein > 1.0g; 16. Pregnant or lactating women;(b) persons with fertility who are unwilling or unable to take effective contraceptive measures; 17. A history of mental illness or substance abuse; 18. The patient had previously received other anti-PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Remission Rate;Disease Control Rate;Life Quality Score; | — |
Countries
China
Contacts
Public ContactGong Wei
Department of Oncology, Dongjin Hospital, Xiangyang Central Hospital
Outcome results
None listed