Liver Cancer
Conditions
Interventions
Treatment group:Radiotherapy with Tislelizumab Injection.
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients should sign informed consent before beginning any treatment. Patients must understand and voluntarily sign a written informed consent. 2.Age 18 to 75 years. 3.Locally advanced hepatocellular carcinoma diagnosed by clinical diagnostic criteria by cytology, histology, or clinical diagnosis by CT, MRI and laboratory examinations (MRI, CT or PET-CT). 4.There was no evidence of common or major branching bile duct invasion. 5.Patients with disease progression after previous other local treatments (e.g., surgery, interventional therapy, ablative therapy, argon helium knife therapy, etc.) or systemic therapy can be included in this study. 6.Radiotherapy is feasible for the patient's liver lesions and portal vein tumor thrombus lesions. 7.The intrahepatic lesions to be radiated had no evidence of direct tumor invasion into the stomach, duodenum, small intestine, large intestine, or diaphragm, and a suitable safe distance from the gastrointestinal tract. 8.The intrahepatic lesion is relatively confined, the liver tumor is less than 60% of the liver volume, it is able to encompass the same target area, and the remaining liver volume outside the radiotherapy target area should be greater than 700 ml. 9.Child-Pugh grade A. 10.Eastern Cooperative Oncology Group (ECOG) score was=1. 11.Hepatitis B surface antigen test should be performed before enrollment, and antiviral drugs should be started 1 week before radiotherapy for patients who are determined to have hepatitis B. 12.During study screening, patients must be tested for hepatitis C virus (HCV) RNA status. Patients with untreated chronic HCV infection are allowed in this study. In addition, patients who are cured of hepatitis C may be enrolled in this study, but hepatitis C treatment should have been completed for more than 4 weeks at the time of enrollment. 13.No significant abnormalities in organ and bone marrow function. Platelet count >= 50×10^9/L, neutrophil absolute value >= 1.5×10^9/L, Hemoglobin=90g/L; Total bilirubin = 29g / L.serum creatinine = 50mL/min. International normalized ratio (INR) <= 2, activated partial thromboplastin time (APTT) <= 1.5×ULN. 14.The expected survival is not less than 3 months. 15.Women of childbearing potential must agree to use an effective method of contraception for at least 30 days prior to study enrollment, during study participation, and for at least 30 days after the last study drug treatment. Women of childbearing potential will be required to undergo a serum pregnancy test within 72 hours prior to initiating treatment. Men treated or enrolled in this trial must agree to use appropriate contraception prior to completion of PD-1 inhibitor treatment and 4 months after treatment. 16.Patients are not enrolled in another clinical trial within 4 weeks prior to screening; if a case fails screening in another trial but meets the requirements of this trial may be enrolled.
Exclusion criteria
Exclusion criteria: 1.Radiotherapy has previously been given to the proposed treatment area. 2.Patients with extrahepatic metastases. 3.Patients with cancerous thrombus invading the superior mesenteric vein. 4.Patients with cancerous thrombus invading inferior vena cava. 5.Patients are currently participating in and receiving other experimental treatments, or participating in an immune checkpoint inhibitor study and receiving investigational treatment. 6.Patients who had been transplantated solid organ diagnosed as immunodeficiency. Patients received systemic steroid therapy or any other immunosuppressive therapy within 7 days before the first trial treatment. 7.The liver tumor is not suitable for radiotherapy. There is a previous history of upper abdominal radiotherapy and radiation irradiation of the liver. 8.Patients had a histologic or cytologic diagnosis of fibrous sheet HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC. 9.Radiation embolization or other selective internal radiotherapy to the liver has been performed. 10.Patiens had bleeding from esophageal or fundal varices within 3 months pre-entry. 11.Patients had hepatic encephalopathy in the past 6 months or significant ascites at enrollment. 12.Patients have active tuberculosis. 13.Patient are allergic to PD-1 inhibitors. 14.The patient has other known aggressive malignancies at the same time (except for those who have no current evidence of tumor recurrence with treatment that has lasted more than 2 years). Exceptions include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, low-risk prostate cancer, or cervical cancer in situ. 15.Patients have prior active autoimmune disease requiring systemic therapy. 16.Patients have active uninfectious pneumonia. 17.Patients who have active infection are required systemic therapy. 18.Patients have known mental illness or substance abuse disorder. 19.Women who are pregnant or breastfeeding. 20.Patients who have treatment with anti-PD-1, anti-PD-L1 drugs must have been discontinued for less than 6 months. 21.Patients had history of human immunodeficiency virus (HIV) (HIV 1/2 antibody). 22.Patients have received vaccine within 30 days prior to the planned start of study treatment. 23.Patients have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure > 140 mmHg, diastolic blood pressure > 100 mmHg); myocardial ischemia or myocardial infarction of CTCAE Class II or higher, poorly controlled arrhythmia, and/or New York Heart Association (NYHA) Class III-IV cardiac insufficiency. 24. Patients who are unable to lie flat or for prolonged periods of time for various reasons. 25.Other conditions that the investigator considered prevent the patient's participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall survival;Progression free survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactQu Yanli
Liaoning Cancer Hospital & Institute
Outcome results
None listed